Sufentanil as Adjuvant of Balanced Anesthesia

NCT ID: NCT03868111

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2020-01-12

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Sufentanil

Balanced anesthesia is maintained with 1 MAC desflurane and sufentanil during laparoscopic cholecystectomy.

Group Type: EXPERIMENTAL

Sufentanil

Intervention Type: DRUG

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

Remifentanil

Balanced anesthesia is maintained with 1 MAC desflurane and remifentanil during laparoscopic cholecystectomy.

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

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

Interventions

Sufentanil

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

Intervention Type: DRUG

Remifentanil

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

Intervention Type: DRUG

Other Intervention Names

Group S; Group R

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kangbuk Samsung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyoung-Ho Ryu, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyoung-Ho Ryu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

Kangbuk Samsung Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2019-02-001

Identifier Type: -

Identifier Source: org_study_id