Comparison of ED95 of Butorphanol with Sufentanil for Gastrointestinal Endoscopy Sedation: a randomized controlled trial

Abstract

Background: Butorphanol, a synthetic opioid partial agonist analgesic, has been widely used for the control of perioperative pain. However, the ideal dose and availability of butorphanol for gastrointestinal (GI) endoscopy are not well known. The aim of this study was to evaluated the 95% effective dose (ED95) of butorphanol and sufentanil in GI endoscopy and compared their clinical efficacy, especially the recovery time.Methods: The study was divided into two parts. For the first part, voluntary patients who needed GI endoscopy anesthesia were recruited to measure the ED95 of butorphanol and sufentanil when they reached successful sedation during GI endoscopy using the sequential method (the Dixon up-anddown method). In the second part, this was a double-blind, randomized study. Two hundred cases of painless GI endoscopy patients were randomly divided into two groups (n=100), including group B (butorphanol at the ED95 dose) and group S (sufentanil at the ED95 dose). Propofol was infused intravenously to both groups as the sedative. The recovery time, VAS (visual analogue scale) score, hand grip strength, fatigue severity scores, incidence of nausea and vomiting, and incidence of dizziness were recorded.Results: The ED95 of butorphanol in painless GI endoscopy was 9.07μg/kg (95% confidence interval: 7.81-19.66μg/kg). The ED95 of sufentanil was 0.1μg/kg (95% CI, 0.079-0.422μg/kg). Both butorphanol and sufentanil provided a good analgesic effect in GI endoscopy. However, the recovery time for butorphanol was significantly shorter than sufentanil (P<0.05, group B versus group S:21.26±7.70 vs. 24.03±7.80, min).Conclusions: Butorphanol at 9.07μg/kg showed a better effect compared with sufentanil in GI endoscopy sedation, notably reduced the recovery time.

Analgesic efficacy of butorphanol combined with sufentanil after heart valve surgery: A propensity score-matching analysis

“…[19] Butorphanol is a derivative of morphinan, which partially antagonizes α-opioid receptors and reduces the incidence of nausea, vomiting, and other postoperative side effects. [20] In a randomized controlled trial of gastrointestinal endoscopic analgesia, [21] butorphanol reduced postoperative nausea and vomiting, possibly due to reduced gastrointestinal motility and smooth muscle spasm, which in turn reduced the incidence of vomiting.…”

Understanding Research Methods: Up-and-down Designs for Dose-finding

“…In view of this, some of these studies added a confirmatory stage enrolling n = 30 to 100 patients and treating them at the estimated higher percentile. 37,40 While some studies reported results that corroborate the off-target estimate, a better use of the additional sample might have been to follow upon the classical up-and-down design with a high-target up-and-down design, using the first stage to refine the dose spacing as suggested earlier in this section.…”

“…, estimating the ED95 using ED50-finding up-and-down design data, a practice that has become prevalent in recent anesthesiology studies). 28,35–40 Such estimates are likely biased in the direction of the ED50 ( i.e. , downward).…”

“…Because this bias increases as the dose gets further from target, it is ill advised to estimate percentiles far from the designated target (e.g., estimating the ED95 using ED50finding up-and-down design data, a practice that has become prevalent in recent anesthesiology studies). 28,[35][36][37][38][39][40] Such estimates are likely biased in the direction of the ED50 (i.e., downward). Furthermore, an ED50-centered up-and-down design would collect few observations near the ends of the dose-response curve, and therefore estimates in that region would rely upon very little direct data.…”

Predominant role of gut-vagus-brain neuronal pathway in postoperative nausea and vomiting: evidence from an observational cohort study

“…This might be duo to: 1) dexamethasone being regularly used in premedication along with intra-operative 5HT3 antagonists; 2) su cient anti-emetic (normally 9 mg ondensteron) accompanying opioid analgetics (butorphanol ± fentanyl at much lower dosage) during postoperative patient-controlled analgesia in our hospital. Butorphanol is less likely to cause PONV [24]. Multivariate logistic regression analysis with factors associated with PONV in entire cohort.…”