Sufentanil as Adjuvant of Balanced Anesthesia

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Drug: Sufentanil; Drug: Remifentanil

• Registration Number: NCT03868111
• Lead Sponsor: Kangbuk Samsung Hospital

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-08
• Study Start: 2019-11-04
• Primary Completion: 2020-01-12
• Study Completion: 2020-01-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sufentanil	Sufentanil	Balanced anesthesia is maintained with 1 MAC desflurane and sufentanil during laparoscopic cholecystectomy.
Remifentanil	Remifentanil	Balanced anesthesia is maintained with 1 MAC desflurane and remifentanil during laparoscopic cholecystectomy.

Primary Outcome Measures

Name	Time	Method
Postoperative wound pain score	10 minutes after surgery	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.

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of