Sufentanil as Adjuvant of Balanced Anesthesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison Between Sufentanil and Remifentanil as General Anesthetic Adjuvant

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Sufentanil
* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sufentanil<br>Balanced anesthesia is maintained with 1 MAC desflurane and sufentanil during laparoscopic cholecystectomy. | Drug: Sufentanil<br>* The infusion rate of sufentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.<br>* Other names: Group S;|
| Experimental: Remifentanil<br>Balanced anesthesia is maintained with 1 MAC desflurane and remifentanil during laparoscopic cholecystectomy. | Drug: Remifentanil<br>* The infusion rate of remifentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.<br>* Other names: Group R;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |