The effect of low- versus normal-pressure pneumoperitoneum during laparoscopic colorectal surgery on the early quality of recovery with perioperative care according to the enhanced recovery principles (RECOVER): study protocol for a randomized controlled study.
ABSTRACT: BACKGROUND:There is increasing evidence for the use of lower insufflation pressures during laparoscopic surgery. Deep neuromuscular blockade allows for a safe reduction in intra-abdominal pressure without compromising the quality of the surgical field. While there is considerable evidence to support superior surgical conditions during deep neuromuscular blockade, there is only a limited amount of studies investigating patient outcomes. Moreover, results are not always consistent between studies and vary between different types of laparoscopic surgery. This study will investigate the effect of low-pressure pneumoperitoneum facilitated by deep NMB on quality of recovery after laparoscopic colorectal surgery. METHODS:The RECOVER study is a multicenter double-blinded randomized controlled trial consisting of 204 patients who will be randomized in a 1:1 fashion to group A, low-pressure pneumoperitoneum (8?mmHg) facilitated by deep neuromuscular blockade (post tetanic count of 1-2), or group B, normal-pressure pneumoperitoneum (12?mmHg) with moderate neuromuscular blockade (train-of-four response of 1-2). The primary outcome is quality of recovery on postoperative day 1, quantified by the Quality of Recovery-40 questionnaire. DISCUSSION:Few studies have investigated the effect of lower insufflation pressures facilitated by deep neuromuscular blockade on patient outcomes after laparoscopic colorectal procedures. This study will identify whether low pressure pneumoperitoneum and deep neuromuscular blockade will enhance recovery after colorectal laparoscopic surgery and, moreover, if this could be a valuable addition to the Enhanced Recovery After Surgery guidelines. TRIAL REGISTRATION:EudraCT 2018-001485-42. Registered on April 9, 2018. Clinicaltrials.govNCT03608436. Registered on July 30, 2018.
Project description:The use of low intra-abdominal pressure (<10 mmHg) reduces postoperative pain scores after laparoscopic surgery.To investigate whether low-pressure pneumoperitoneum with deep neuromuscular blockade improves the quality of recovery after laparoscopic donor nephrectomy (LDN).In a single-center randomized controlled trial, 64 live kidney donors were randomly assigned to 6 or 12 mmHg insufflation pressure. A deep neuromuscular block was used in both groups. Surgical conditions were rated by the five-point Leiden-surgical rating scale (L-SRS), ranging from 5 (optimal) to 1 (extremely poor) conditions. If the L-SRS was insufficient, the pressure was increased stepwise.The primary outcome measure was the overall score on the quality of recovery-40 (QOR-40) questionnaire at postoperative day 1.The difference in the QOR-40 scores on day 1 between the low- and standard-pressure group was not significant (p = .06). Also the overall pain scores and analgesic consumption did not differ. Eight procedures (24%), initially started with low pressure, were converted to a standard pressure (≥10 mmHg). A L-SRS score of 5 was significantly more prevalent in the standard pressure as compared to the low-pressure group at 30 min after insufflation (p < .01).Low-pressure pneumoperitoneum facilitated by deep neuromuscular blockade during LDN does not reduce postoperative pain scores nor improve the quality of recovery in the early postoperative phase. The question whether the use of deep neuromuscular blockade during laparoscopic surgery reduces postoperative pain scores independent of the intra-abdominal pressure should be pursued in future studies.The trial was registered at clinicaltrial.gov before the start of the trial (NCT02146417).
Project description:BACKGROUND:A recent study shows that a multifaceted strategy using an individualised intra-abdominal pressure titration strategy during colorectal laparoscopic surgery results in an acceptable workspace at low intra-abdominal pressure in most patients. The multifaceted strategy, focused on lower to individualised intra-abdominal pressures, includes prestretching the abdominal wall during initial insufflation, deep neuromuscular blockade, low tidal volume ventilation settings and a modified lithotomy position. The study presented here tests the hypothesis that this strategy improves outcomes of patients scheduled for colorectal laparoscopic surgery. METHODS:The Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery versus Standard Therapy (IPPCollapse-II) study is a multicentre, two-arm, parallel-group, single-blinded randomised 1:1 clinical study that runs in four academic hospitals in Spain. Patients scheduled for colorectal laparoscopic surgery with American Society of Anesthesiologists classification I to III who are aged >?18?years and are without cognitive deficits are randomised to an individualised pneumoperitoneum pressure strategy (the intervention group) or to a conventional pneumoperitoneum pressure strategy (the control group). The primary outcome is recovery assessed with the Post-operative Quality of Recovery Scale (PQRS) at postoperative day 1. Secondary outcomes include PQRS score in the post anaesthesia care unit and at postoperative day 3, postoperative complications until postoperative day 28, hospital length of stay and process-related outcomes. DISCUSSION:The IPPCollapse-II study will be the first randomised clinical study that assesses the impact of an individualised pneumoperitoneum pressure strategy focused on working with the lowest intra-abdominal pressure during colorectal laparoscopic surgery on relevant patient-centred outcomes. The results of this large study, to be disseminated through conference presentations and publications in international peer-reviewed journals, are of ultimate importance for optimising the care and safety of laparoscopic abdominal surgery. Selection of patient-reported outcomes as the primary outcome of this study facilitates the translation into clinical practice. Access to source data will be made available through anonymised datasets upon request and after agreement of the Steering Committee of the IPPCollapse-II study. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02773173 . Registered on 16 May 2016. EudraCT, 2016-001693-15. Registered on 8 August 2016.
Project description:BACKGROUND:Deep neuromuscular blockade may facilitate the use of reduced insufflation pressure without compromising the surgical field of vision. The current evidence, which suggests improved surgical conditions compared with other levels of block during laparoscopic surgery, features significant heterogeneity. We examined surgical patient- and healthcare resource use-related outcomes of deep neuromuscular blockade compared with moderate neuromuscular blockade in adults undergoing laparoscopic surgery. METHODS:We conducted a systematic literature review according to the quality standards recommended by the Cochrane Handbook for Systematic Reviews. Randomized controlled trials comparing outcomes of deep neuromuscular blockade and moderate neuromuscular blockade among adults undergoing laparoscopic surgeries were included. A random-effects model was used to conduct pair-wise meta-analyses. RESULTS:The systematic literature review included 15 studies-only 13 were analyzable in the meta-analysis and none were judged to be at high risk of bias. Compared with moderate neuromuscular blockade, deep neuromuscular blockade was associated with improved surgical field of vision and higher vision quality scores. Also, deep neuromuscular blockade was associated with a reduction in the post-operative pain scores in the post-anesthesia care unit compared with moderate neuromuscular blockade, and there was no need for an increase in intra-abdominal pressure during the surgical procedures. There were minor savings on resource utilization, but no differences were seen in recovery in the post-anesthesia care unit or overall length of hospital stay with deep neuromuscular blockade. CONCLUSIONS:Deep neuromuscular blockade may aid the patient and physician surgical experience by improving certain patient outcomes, such as post-operative pain and improved surgical ratings, compared with moderate neuromuscular blockade. Heterogeneity in the pooled estimates suggests the need for better designed randomized controlled trials.
Project description:BACKGROUND:Patients with diabetes mellitus are at a high risk of developing postoperative acute kidney injury. For patients receiving laparoscopic surgery, standard-pressure pneumoperitoneum (SPP) currently applied in clinical practice also undermines renal perfusion. Several studies have shown that low-pressure pneumoperitoneum (LPP) might reduce pressure-related ischemic renal injury. However, LPP may compromise the view of the surgical field. Previous studies have indicated that deep neuromuscular blockade (NMB) can ameliorate this issue. However, the conclusion is still uncertain. The hypothesis of this study is that the joint use of LPP and deep NMB can reduce perioperative renal injury in diabetic patients undergoing laparoscopic pelvic surgery without impeding the view of the surgical field. METHODS:This is a double-blinded, randomized controlled trial using a 2?×?2 factorial trial design. A total of 648 diabetes patients scheduled for major laparoscopic pelvic surgeries at Peking Union Medical College Hospital will be randomized into the following four groups: SPP (12-15?mmHg)?+?deep-NMB (post-tetanic count of 1-2) group, LPP (7-10?mmHg)?+?deep-NMB group, SPP?+?moderate-NMB (train-of-four of 1-2) group, and LPP?+?moderate-NMB group. The primary outcome is serum cystatin C level measured before insufflation, after deflation, 24?h postoperatively, and 72?h postoperatively. The secondary outcomes are serum creatinine level, intraoperative urine output, erythrocytes in urinary sediment, renal tissue oxygen saturation, Leiden's surgical condition rating scale, surgery duration, and occurrence of bucking or body movement. DISCUSSION:This study will provide evidence for the effect of LPP on renal function protection in patients with diabetes undergoing laparoscopic pelvic surgery. The trial can also help us to understand whether deep NMB can improve surgical conditions. TRIAL REGISTRATION:ClinicalTrials.gov : NCT04259112 . Prospectively registered on 5 February 2020.
Project description:Since technique modifications of laparoscopic donor nephrectomy, e.g. retroperitoneoscopic donor nephrectomy or hand-assistance, have not shown significant benefit regarding safety or improvement of recovery, further research should focus on improving postoperative recovery. The use of low pressure pneumoperitoneum has shown to significantly reduce postoperative pain after laparoscopy. To facilitate the use of low pressure pneumoperitoneum, deep neuromuscular block will be used.This trial is a phase IV, single center, double-blind, randomized controlled clinical trial in which 64 patients will be randomized to: low pressure pneumoperitoneum (6 mmHg) and deep neuromuscular block or normal pressure pneumoperitoneum (12 mmHg) and deep neuromuscular block. Deep neuromuscular block is defined as post tetanic count < 5. Primary outcome measurement will be Quality of Recovery-40 questionnaire (overall score) on day 1.This study is the first randomized study to assess the combination of low pressure pneumoperitoneum in combination with deep neuromuscular block from a patients' perspective. The study findings may also be applicable for other laparoscopic procedures.The trial was registered at trials.gov (NCT02146417) in July 2014.
Project description:Carbon dioxide (CO2) absorption and increased intra-abdominal pressure can adversely affect perioperative physiology and postoperative recovery. Deep muscle relaxation is known to improve the surgical conditions during laparoscopic surgery. We aimed to compare the effects of deep and moderate neuromuscular block in laparoscopic colorectal surgery, including intra-abdominal pressure. In this prospective, double-blind, parallel-group trial, 72 adult patients undergoing laparoscopic colorectal surgery were randomized using an online randomization generator to achieve either moderate (1-2 train-of-four response, n?=?36) or deep (1-2 post-tetanic count, n?=?36) neuromuscular block by receiving a continuous infusion of rocuronium. Adjusted intra-abdominal pressure, which was titrated by a surgeon with maintaining the operative field during pneumoperitoneum, was recorded at 5-minute intervals. Perioperative hemodynamic parameters and postoperative outcomes were assessed. Six patients from the deep and 5 from the moderate neuromuscular block group were excluded, leaving 61 for analysis. The average adjusted IAP was lower in the deep compared to the moderate neuromuscular block group (9.3 vs 12 mm Hg, P?<?0.001). The postoperative pain scores (P?<?0.001) and incidence of postoperative shoulder tip pain were lower, whereas gas passing time (P?=?0.002) and sips of water time (P?=?0.005) were shorter in the deep neuromuscular block than in the moderate neuromuscular block group. Deep neuromuscular blocking showed several benefits compared to conventional moderate neuromuscular block, including a greater intra-abdominal pressure lowering effect, whereas surgical conditions are maintained, less severe postoperative pain and faster bowel function recovery.
Project description:Postoperative recovery after live donor nephrectomy is largely determined by the consequences of postoperative pain and analgesia consumptions. The use of deep neuromuscular blockade has been shown to reduce postoperative pain scores after laparoscopic surgery. In this study, we will investigate whether deep neuromuscular blockade also improves the early quality of recovery after live donor nephrectomy.The RELAX-study is a phase IV, multicenter, double-blinded, randomized controlled trial, in which 96 patients, scheduled for living donor nephrectomy, will be randomized into two groups: one with deep and one with moderate neuromuscular blockade. Deep neuromuscular blockade is defined as a post-tetanic count of 1-2. Our primary outcome measurement will be the Quality of Recovery-40 questionnaire (overall score) at 24 h after extubation.This study is, to our knowledge, the first randomized study to assess the effectiveness of deep neuromuscular blockade during laparoscopic donor nephrectomy in enhancing postoperative recovery. The study findings may also be applicable for other laparoscopic procedures.clinicaltrials.gov, NCT02838134 . Registered on 29 June 2016.
Project description:BACKGROUND:There has been no study of the effect of post end-expiratory pressure (PEEP) on intraocular or intracranial pressure during pneumoperitoneum with steep Trendelenburg positioning. We investigated the effects of 5?cmH2O of PEEP on intraocular pressure and optic nerve sheath diameter as a surrogate for intracranial pressure in robot-assisted laparoscopic radical prostatectomy. METHODS:Fifty patients scheduled for robot-assisted laparoscopic radical prostatectomy were divided into a zero-PEEP (ZEEP) group and a 5?cmH2O of PEEP (PEEP) group. Intraocular pressure, optic nerve sheath diameter, and respiratory and hemodynamic parameters were measured before induction (T0), 10?minutes after induction of general anesthesia in the supine position before CO2 insufflation (T1), 5?minutes (T2), and 30?minutes (T3) after steep Trendelenburg positioning with pneumoperitoneum, after desufflation of pneumoperitoneum in the supine position (T4), and after 30?minutes in the recovery room postoperatively (T5). RESULTS:There was no significant difference in intraocular pressure or optic nerve sheath diameter between the groups during the study. The partial pressure of arterial oxygen and dynamic lung compliance at T1, T2, T3, and T4 were significantly higher in the PEEP than in the ZEEP group. There was no difference in mean arterial pressure or heart rate between groups at any time. CONCLUSION:Applying 5?cmH2O of PEEP did not increase intraocular pressure or optic nerve sheath diameter during pneumoperitoneum with steep Trendelenburg positioning in robot-assisted laparoscopic radical prostatectomy. These results suggest that low PEEP can be safely applied during surgery with pneumoperitoneum and steep Trendelenburg positioning in patients without preexisting eye disease and brain pathology.
Project description:BACKGROUND:Deep neuromuscular block is associated with improved working conditions during laparoscopic surgery when propofol is used as a general anaesthetic. However, whether deep neuromuscular block yields similar beneficial effects when anaesthesia is maintained using volatile inhalation anaesthesia has not been systematically investigated. Volatile anaesthetics, as opposed to intravenous agents, potentiate muscle relaxation, which potentially reduces the need for deep neuromuscular block to obtain optimal surgical conditions. We examined whether deep neuromuscular block improves surgical conditions over moderate neuromuscular block during sevoflurane anaesthesia. METHODS:In this single-centre, prospective, randomised, double-blind study, 98 patients scheduled for elective renal surgery were randomised to receive deep (post-tetanic count 1-2 twitches) or a moderate neuromuscular block (train-of-four 1-2 twitches). Anaesthesia was maintained with sevoflurane and titrated to bispectral index values between 40 and 50. Pneumoperitoneum pressure was maintained at 12 mm Hg. The primary outcome was the difference in surgical conditions, scored at 15 min intervals by one of eight blinded surgeons using a 5-point Leiden-Surgical Rating Scale (L-SRS) that scores the quality of the surgical field from extremely poor1 to optimal5. RESULTS:Deep neuromuscular block did not improve surgical conditions compared with moderate neuromuscular block: mean (standard deviation) L-SRS 4.8 (0.3) vs 4.8 (0.4), respectively (P=0.94). Secondary outcomes, including unplanned postoperative readmissions and prolonged hospital admission, were not significantly different. CONCLUSIONS:During sevoflurane anaesthesia, deep neuromuscular block did not improve surgical conditions over moderate neuromuscular block in normal-pressure laparoscopic renal surgery. CLINICAL TRIAL REGISTRATION:NL7844 (www.trialregister.nl).
Project description:Background and Aims:Pulse pressure variation (?PP) is considered as one of the best predictors of fluid responsiveness in patients under mechanical ventilation. Pleth Variability Index (PVI) has been proposed as a noninvasive alternative. However, pneumoperitoneum has been recently suggested as a limitation to their interpretation. The aim of this study was to compare changes in ?PP and PVI related to autotransfusion associated with a Trendelenburg maneuver before and during pneumoperitoneum. Methods:50 patients undergoing elective abdominal laparoscopic surgery were enrolled in this prospective observational study. All patients were equipped with an invasive radial artery catheter and a PVI probe. After obtaining a stable signal with both ?PP and PVI, baseline values were recorded, before and after head-down tilts of 10°, with or without abdominal insufflation (10-12 mmHg). All measurements were made before any fluid challenge under standardized anaesthesia, while patients were paralyzed and mechanically ventilated with 8 mL/kg tidal volume. Results:Changes in ?PP and PVI associated with the Trendelenburg maneuver before and after insufflation of the pneumoperitoneum were significantly different (P < 0.001). In baseline conditions, the Trendelenburg maneuver was associated with a significant decrease in heart rate while mean arterial pressure remained unchanged. Both ?PP and PVI decreased. After insufflation of the pneumoperitoneum, the Trendelenburg maneuver was associated with a significant decrease in heart rate and ?PP and an increase in mean arterial pressure while PVI remained unchanged. Conclusion:Pneumoperitoneum did not alter the response of ?PP to autotransfusion associated with the Trendelenburg maneuver, which was not the case for the PVI. This latter decreased during Trendelenburg maneuver performed alone and remained unchanged during Trendelenburg maneuver performed after insufflation of the pneumoperitoneum.