Sufentanil as Adjuvant of Balanced Anesthesia

Kangbuk Samsung Hospital66 enrolled

Overview

The aim of the study was to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced general anesthesia.

The investigators hypothesized that sufentanil would reduce postoperative pain than remifentanil without prolonging recovery times in minor laparoscopic surgery when administered equivalent antinociceptive doses during surgery. Intraoperative opioid administration for equivalent nociception-antinociception balance could be achieved via surgical pleth index (SPI)-guided analgesia. This study was designed to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced anesthesia in patients undergoing laparoscopic cholecystectomy under SPI-guided opioid administration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Anesthesia

Interventions

SufentanilDRUG

The infusion rate of sufentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.

RemifentanilDRUG

The infusion rate of remifentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged between 19 and 65 years * Patients with American Society of Anesthesiologists physical status I or II * Patients scheduled for elective laparoscopic cholecystectomy under balanced general anesthesia for benign cholecystic diseases * Patients obtaining written informed consent Exclusion Criteria: * Patients with asthma or hypertension * Patients with an inability to express their pain accurately * Patients with an inability to understand the pain scale * Patients with chronic abdominal pain or chronic pain syndrome * Patients who required to convert to laparotomy from laparoscopic surgery * Patients who required to receive incidental lower abdominal procedures owing to adhesion, injury, or other incidental findings at the lower abdominal cavity * Patients with a history of drug or alcohol abuse * Pregnant women

Locations (1)

Kangbuk Samsung Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Postoperative wound pain score

The pain score is evaluated by 10 point visual analogue scale at post-anesthesia care unit. The visual analogue scale is presented as a 10-cm line with verbal descriptors indicating "no pain" and "pain as bad as it could be". The visual analogue scale ranges from 0 to 10, representing minimum and maximum pain levels, respectively.

Time frame: 10 minutes after surgery

Data from ClinicalTrials.gov

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