Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia (CARAN)

Nanjing Medical University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Butorphanol tartrate; Drug: Fentanyl citrate; Drug: Sufentanil citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT00738192

NJFY0807311M

NMU-FY2008-311

Details and patient eligibility

About

Fast awakening from anesthesia is one of the major characteristics of remifentanil-associated anesthetic induction and maintenance, whereas corresponding pain during awakening influences patient's rehabilitation strongly. In addition, such early postoperative pain results in significant stress responses, which displays as further release of stress hormones such as cortisol and β-endorphin as well. How to prevent such acute pain resulting from remifentanil's fast metabolism endows clinical significance. This study is designed to compare the analgesic efficacy of fentanyl, sufentanil and butorphanol delivered after gynecological laparoscopic surgeries that underwent remifentanil induction and maintenance, and investigate corresponding influence on the levels of blood cortisol and β-endorphin.

Enrollment: 150 patients

Sex: Female

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ASA physical status I-II
2. Chinese
3. 19-45yr
4. Selective laparoscopic surgeries

Exclusion criteria

1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
2. Participants younger than 18 years, older than 45 years or pregnancy was eliminated
3. Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study
4. Those who were not willing to or could not finish the whole study at any time

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups

1

Active Comparator group

Description:

Fentanyl delivered for controlling awaking pain

Treatment:

Drug: Fentanyl citrate

2

Active Comparator group

Description:

Sufentanil delivered for controlling awaking pain

Treatment:

Drug: Sufentanil citrate

3

Active Comparator group

Description:

Butorphanol delivered for controlling awaking pain

Treatment:

Drug: Butorphanol tartrate