Sufentanil as Adjuvant of Balanced Anesthesia

Anesthesia Clinical Trial

Official title:

Comparison Between Sufentanil and Remifentanil as General Anesthetic Adjuvant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868111
• Other study ID #: 2019-02-001
• Status: Completed
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: January 12, 2020

Study information

• Verified date: June 2020
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 12, 2020
• Est. primary completion date: January 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Sufentanil
The infusion rate of sufentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.
• Remifentanil
The infusion rate of remifentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes after surgery