Anesthesia
Conditions
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.
Interventions
DRUGSufentanil
The infusion rate of sufentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.
DRUGRemifentanil
The infusion rate of remifentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.
Sponsors
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed