Doxapram as an additive to propofol sedation for endoscopic retrograde cholangiopancreatography: a placebo-controlled, randomized, double-blinded study.
ABSTRACT: BACKGROUND:Endoscopic retrograde cholangiopancreatography (ERCP) requires moderate to deep sedation, usually with propofol. Adverse effects of propofol sedation are relatively common, such as respiratory and cardiovascular depression. This study was conducted to determine if doxapram, a respiratory stimulant, could be used to reduce the incidence of respiratory depression. METHODS:This is a single-center, prospective randomized double-blind study performed in the endoscopy unit of Helsinki University Central Hospital. 56 patients were randomized in a 1:1 ratio to either receive doxapram as an initial 1 mg/kg bolus and an infusion of 1 mg/kg/h (group DOX) or placebo (group P) during propofol sedation for ERCP. Main outcome measures were apneic episodes and hypoxemia (SpO2?
Project description:Introduction:Bispectral index (BIS) monitoring provides an objective, non-invasive measurement of the level of consciousness in a sedated patient. Aim:In this prospective study, we aimed to investigate the hypothesis that risk of respiratory depression could be reduced and the desired level of sedation with minimal doses of propofol could be achieved by using BIS monitoring in endoscopic retrograde cholangiopancreatography (ERCP) procedures. Material and methods:Sixty patients in the ASA 1-2 category, who were scheduled for an ERCP with sedation, were randomly divided into two groups. The procedure was performed, and sedation was administered so that the patient's Ramsay Sedation Score (RSS) would be 4-5 in the first group (group 1) and the patient's BIS value would be 65-75 in the second group (group 2). Cardiopulmonary complications, the total duration of the procedure, and the total amount of propofol administered were recorded. Results:The mean SpO2 measurements at the third minute, fifth minute, and 10th minute were higher in the BIS group (p < 0.001) (p < 0.05). The mean number of respirations during the third, fifth, 10th, and 15th minute of sedation was significantly higher in the RSS group than in the BIS group (p < 0.05). There was no difference between the groups in terms of recovery time, total propofol amount, and additional doses of bolus propofol. Conclusions:BIS monitoring during sedation with propofol for ERCP did not reduce total propofol use, but it may be an efficient guide for the timing of additional dose administration, which could reduce the risk of respiratory depression, and it could be used safely as an objective method in the follow-up of level of sedation.
Project description:The importance of providing effective analgesia during sedation for complex endoscopic procedures has been widely recognized. However, repeated administration of opioids in order to achieve sufficient analgesia may carry the risk of delayed recovery after propofol based sedation. This study was done to compare recovery profiles and the satisfaction of the endoscopists and patients between conventional balanced propofol sedation and analgesia-oriented combination sedation for patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).Two hundred and two adult patients scheduled for ERCP were sedated by either the Conventional (initial bolus of meperidine with propofol infusion) or Combination (repeated bolus doses of fentanyl with propofol infusion) method. Recovery profiles, satisfaction levels of the endoscopists and patients, drug requirements and complications were compared between groups.Patients of the Combination Group required significantly less propofol compared to the Conventional Group (135.0 ± 68.8 mg vs. 165.3 ± 81.7 mg, P = 0.005). Modified Aldrete scores were not different between groups throughout the recovery period, and recovery times were also comparable between groups. Satisfaction scores were not different between the two groups in both the endoscopists and patients (P = 0.868 and 0.890, respectively).Considering the significant reduction in propofol dose, the non-inferiority of recovery profiles and satisfaction scores of the endoscopists and patients, analgesia oriented combination sedation may be a more safe yet effective sedative method compared to conventional balanced propofol sedation during ERCP.
Project description:BACKGROUND:Endoscopic Retrograde Cholangiopancreatography (ERCP) is a complex endoscopic procedure that requires moderate to deep sedation. Propofol is the sedative agent of choice for sedation in ERCP due to its fast distribution and fast elimination time without a cumulative effect after infusion, resulting in shorter recovery time. Benzydamine hydrochloride is a topical non-steroidal anti-inflammatory drug that has analgesic, local anesthetic, and anti-inflammatory effects that have been known to be effective in reducing postoperative sore throat. Combination of propofol and topical analgesic may provide adequate sedation and reduce propofol consumption. This study aimed to determine the effectivity of benzydamine hydrochloride gargling in reducing propofol consumption in the ERCP procedure. METHODS:This study was a single-blind randomized controlled trial for patients undergoing ERCP procedures at Cipto Mangunkusumo Hospital from August to September 2018. A total of 72 subjects were recruited consecutively and randomly assigned into two groups. The first group received 15?mL of 0.15% benzydamine hydrochloride mouthwash prior to the procedure, whereas the second group received 15?mL of water mouthwash. Additional propofol was administered when patient moved or Ramsay Sedation Scale rose above 4. Cumulative propofol consumption per kg body weight per minute and incidence of postoperative sore throat were recorded in each group. Incidence of desaturation, postoperative nausea vomitting, and dysphagia were also recorded. Data analysis was performed with Statistical Package for the Social Sciences. RESULTS:Cumulative propofol consumption per minute per kg body weight in the benzydamine hydrochloride group was 152.7 (91.9-238.8) mcg/kg/minute, while in the control group was 200.05 (114.4-380.2) mcg/kg/ minute (p?=?<?0.001). The incidence of sore throat on the 0th, 2nd, and 4th hour for the benzydamine hydrochloride group was 11.4, 11.4, and 5.7%, while in the control group was 50, 52.8, and 36.1% (p?=?<?0.001, <?0.001, 0.003). Desaturation was found in control group whereas none in benzydamine hydrochloride group. Complaints of nausea and vomiting were comparable in both groups. CONCLUSION:Benzydamine hydrochloride gargling was effective in reducing cumulative propofol consumption in the ERCP procedure. TRIAL REGISTRATION:Study was registered retrospectively in ClinicalTrials.gov with NCT04167592 on November 8th 2019.
Project description:Endoscopic retrograde cholangiopancreatography (ERCP) in the UK has been historically performed under conscious sedation. However, given the increasing complexity of cases, the role of propofol-assisted ERCP (propERCP) is increasing. We describe our experience of propERCP and highlight the importance of this service.Our prospective ERCP database was interrogated between January 2013 and January 2014. Data collection included procedural information, patient demographics, American Association of Anaesthesiologists (ASA) status, Cotton grade of endoscopic difficulty and endoscopic and anaesthetic complications. Comparison was made with patients undergoing conscious sedation ERCP (sedERCP).744 ERCPs were performed in 629 patients (53% male). 161 ERCPs were performed under propofol. PropERCP patients were younger compared with the sedERCP group (54 vs 66 years, p<0.0001) but ASA grade 1-2 status was similar (84% vs 78%, p=0.6). An increased number of Cotton grade 3-4 ERCPs were performed in the propERCP group (64% vs 34%, p<0.0001). Indications for propERCP included sphincter of Oddi manometry (27%), previously poorly tolerated sedERCP (26%), cholangioscopy (21%) and patient request (8%). 77% of cases were elective, 12% were urgent day-case transfers and 11% were urgent inpatients. 59% of cases were tertiary referrals. ERCP was completed successfully in 95% of cases. Anaesthetic and endoscopic complications were comparable between the two groups (5% and 7% vs 3% and 5%). Where sedERCP had been unsuccessful due to patient intolerance, the procedure was completed successfully using propofol.PropERCP is safe and is associated with high endoscopic success. The need for propERCP is likely to increase given patient preference and the high proportion of complex procedures being undertaken. All endoscopy units should look to incorporate propofol-assisted endoscopy into aspects of their services.
Project description:ERCP practically requires moderate to deep sedation controlled by a combination of benzodiazepine and opiod. Propofol as a sole agent may cause oversedation. A combination (cocktail) of infused propofol, meperidine, and midazolam can reduce the dosage of propofol and we hypothesized that it might decrease the risk of oversedation. We prospectively compare the efficacy, recovery time, patient satisfactory, and side effects between cocktail and conventional sedations in patients undergoing ERCP.ERCP patients were randomized into 2 groups; the cocktail group (n?=?103) and the controls (n?=?102). For induction, a combination of 25?mg of meperidine and 2.5?mg of midazolam were administered in both groups. In the cocktail group, a bolus dose of propofol 1?mg/kg was administered and continuously infused. In the controls, 25?mg of meperidine or 2.5?mg/kg of midazolam were titrated to maintain the level of sedation.In the cocktail group, the average administration rate of propofol was 6.2?mg/kg/hr. In the control group; average weight base dosage of meperidine and midazolam were 1.03?mg/kg and 0.12?mg/kg, respectively. Recovery times and patients' satisfaction scores in the cocktail and control groups were 9.67?minutes and 12.89?minutes (P?=?0.045), 93.1and 87.6 (P <0.001), respectively. Desaturation rates in the cocktail and conventional groups were 58.3% and 31.4% (P <0.001), respectively. All desaturations were corrected with temporary oxygen supplementation without the need for scope removal.Cocktail sedation containing propofol provides faster recovery time and better patients' satisfaction for patients undergoing ERCP. However, mild degree of desaturation may still develop.ClinicalTrials.gov, NCT01540084.
Project description:There are safety issues associated with propofol use for flexible bronchoscopy (FB). The bispectral index (BIS) correlates well with the level of consciousness. The aim of this study was to show that BIS-guided propofol infusion is safe and may provide better sedation, benefiting the patients and bronchoscopists.After administering alfentanil bolus, 500 patients were randomized to either propofol infusion titrated to a BIS level of 65-75 (study group) or incremental midazolam bolus based on clinical judgment to achieve moderate sedation. The primary endpoint was safety, while the secondary endpoints were recovery time, patient tolerance, and cooperation.The proportion of patients with hypoxemia or hypotensive events were not different in the 2 groups (study vs. control groups: 39.9% vs. 35.7%, p?=?0.340; 7.4% vs. 4.4%, p?=?0.159, respectively). The mean lowest blood pressure was lower in the study group. Logistic regression revealed male gender, higher American Society of Anesthesiologists physical status, and electrocautery were associated with hypoxemia, whereas lower propofol dose for induction was associated with hypotension in the study group. The study group had better global tolerance (p<0.001), less procedural interference by movement or cough (13.6% vs. 36.1%, p<0.001; 30.0% vs. 44.2%, p?=?0.001, respectively), and shorter time to orientation and ambulation (11.7±10.2 min vs. 29.7±26.8 min, p<0.001; 30.0±18.2 min vs. 55.7±40.6 min, p<0.001, respectively) compared to the control group.BIS-guided propofol infusion combined with alfentanil for FB sedation provides excellent patient tolerance, with fast recovery and less procedure interference.ClinicalTrials. gov NCT00789815.
Project description:Background and objectives: Flexible bronchoscopy has been widely used for diagnosis and intervention, while various drugs are used for sedation during bronchoscopy. We examined two regular standardized sedation options (with or without dexmedetomidine) regularly used in our regional hospital. The aim was to assess the efficacy and safety of dexmedetomidine on conscious sedation under bronchoscopy. Materials and Methods: A retrospective chart review was conducted from April 2017 to March 2018. All patients undergoing flexible bronchoscopy with moderate sedation were enrolled. Patients having received dexmedetomidine-propofol-fentanyl were defined as group D, and those having received midazolam-propofol-fentanyl were defined as group M. The primary outcome was a safety profile during the procedure, including the incidence of procedural interference by patient cough or movement, transient hypoxemia, and hypotension. The secondary outcome was measured by the recovery profile (awake and ambulation time). Results: Thirty-five patients in group D and thirty-three in group M were collected in this retrospective study. All patients underwent the procedure successfully. Group D showed higher safety with fewer procedural interference incidences by cough or body movement than Group M (3.3% versus 36.3%, p < 0.001) and minor respiratory adverse effects. Patients in group D showed faster recovery in a shorter ambulation time than group M (24.9 ± 9.7 versus 31.5 ± 11.9, p = 0.02). In group D, bronchoscopist satisfaction to sedation was higher than group M (p = 0.01). More transient bradycardia episodes were noted in patients receiving dexmedetomidine (p < 0.05), but all recovered without atropine intervention. Overall post-procedural adverse events and satisfaction were comparable in the two groups. Conclusions: The co-administration of dexmedetomidine met the safety and recovery demands of flexible bronchoscopy. Compared to the conventional midazolam-propofol-fentanyl regimen, the application of dexmedetomidine improved sedative effectiveness with less procedural interruptions, shorter time to ambulation and higher bronchoscopist satisfaction.
Project description:We hypothesize that capnography could detect hypoventilation during induction of bronchoscopic sedation and starting bronchoscopy following hypoventilation, may decrease hypoxemia. Patients were randomized to: starting bronchoscopy when hypoventilation (hypopnea, two successive breaths of at least 50% reduction of the peak wave compared to baseline or apnea, no wave for 10?seconds) (Study group, n?=?55), or when the Observer Assessment of Alertness and Sedation scale (OAAS) was less than 4 (Control group, n?=?59). Propofol infusion was titrated to maintain stable vital signs and sedative levels. The hypoventilation during induction in the control group and the sedative outcome were recorded. The patient characteristics and procedures performed were similar. Hypoventilation was observed in 74.6% of the patients before achieving OAAS?<?4 in the control group. Apnea occurred more than hypopnea (p?<?0.0001). Hypoventilation preceded OAAS?<?4 by 96.5?±?88.1?seconds. In the study group, the induction time was shorter (p?=?0.03) and subjects with any two events of hypoxemia during sedation, maintenance or recovery were less than the control group (1.8 vs. 18.6%, p?<?0.01). Patient tolerance, wakefulness during sedation, and cooperation were similar in both groups. Significant hypoventilation occurred during the induction and start bronchoscopy following hypoventilation may decrease hypoxemia without compromising patient tolerance.
Project description:Target-controlled infusion (TCI) provides precise pharmacokinetic control of propofol concentration in the effect-site (Ce), eg. brain. This pilot study aims to evaluate the feasibility and optimal TCI regimen for flexible bronchoscopy (FB) sedation.After alfentanil bolus, initial induction Ce of propofol was targeted at 2 ?g/ml. Patients were randomized into three titration groups (i.e., by 0.5, 0.2 and 0.1 ?g/ml, respectively) to maintain stable sedation levels and vital signs. Adverse events, frequency of adjustments, drug doses, and induction and recovery times were recorded.The study was closed early due to significantly severe hypoxemia events (oxyhemoglobin saturation <70%) in the group titrated at 0.5 ?g/ml. Forty-nine, 49 and 46 patients were enrolled into the 3 respective groups before study closure. The proportion of patients with hypoxemia events differed significantly between groups (67.3 vs. 46.9 vs. 41.3%, p?=?0.027). Hypotension events, induction and recovery time and propofol doses were not different. The Ce of induction differed significantly between groups (2.4±0.5 vs. 2.1±0.4 vs. 2.1±0.3 ?g/ml, p?=?0.005) and the Ce of procedures was higher at 0.5 ?g/ml titration (2.4±0.5 vs. 2.1±0.4 vs. 2.2±0.3 ?g/ml, p?=?0.006). The adjustment frequency tended to be higher for titration at 0.1 ?g/ml but was not statistically significant (2 (0?6) vs. 3 (0?6) vs. 3 (0?11)). Subgroup analysis revealed 14% of all patients required no further adjustment during the whole sedation. Comparing patients requiring at least one adjustment with those who did not, they were observed to have a shorter induction time (87.6±34.9 vs. 226.9±147.9 sec, p<0.001), a smaller induction dose and Ce (32.5±4.1 vs. 56.8±22.7 mg, p<0.001; 1.76±0.17 vs. 2.28 ±0.41, p<0.001, respectively), and less hypoxemia and hypotension (15.8 vs.56.9%, p?=?0.001; 0 vs. 24.1%, p?=?0.008, respectively).Titration at 0.5 ?g/ml is risky for FB sedation. A subgroup of patients required no more TCI adjustment with fewer complications. Further studies are warranted to determine the optimal regimen of TCI for FB sedation.ClinicalTrials.gov NCT01101477.
Project description:Alfentanil in combination with propofol produces a synergistic sedative effect in patients undergoing flexible bronchoscopy (FB). However, the use of this combination is controversial due to the risk of cardiopulmonary depression. The aim of this study was to evaluate the proper induction regimen of alfentanil in propofol target-controlled infusion for FB sedation.One hundred seventy-three patients were assigned randomly into 5 regimens: Group 1 and 2, alfentanil 2.5 and 5 μg/kg, respectively, immediately before propofol administration; Group 3 and 4, alfentanil 2.5 and 5 μg/kg, respectively, 2 minutes before propofol administration; and Group 5, propofol administration alone to achieve the observer assessment of alertness and sedation scale 3∼2. The bronchoscopists, physicians in charge of sedation, and patients were blind to the regimens. Adverse events, drug dose, induction, procedure and recovery time, cough severity, and propofol injection related pain were recorded.The patients in groups 2 and 4 required a lower dose of propofol (P = 0.031 and 0.019, respectively) and shorter time (P = 0.035 and 0.010) than group 5 for induction. Patients in group 2 experienced more hypoxemia than those in group 5 during induction (P = 0.031). The physician in charge of sedation scored a lower severity of cough in the patients in group 4 than in groups 3 and 5. There were no differences in terms of propofol injection related pain among the groups.Alfentanil 5 μg/kg given immediately before propofol infusion cannot be recommended. Further study is required to define conclusions about alfentanil 2.5 and 5 μg/kg because of the low power rating of subgroup in the present study.