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Completed

NCT Number: NCT00738192

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA physical status I-II
  • Chinese
  • 19-45yr
  • Selective laparoscopic surgeries

Exclusion criteria

  • Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
  • Participants younger than 18 years, older than 45 years or pregnancy was eliminated
  • 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
  • Those who were not willing to or could not finish the whole study at any time

Treatment and study plan

Fentanyl Citrate

Drug

Fentanyl 0.5 μg/kg delivered intravenously immediate at the end of remifentanil pump finished

Other names: Fentanil

Sufentanil Citrate

Drug

Sufentanil 0.05 μg/kg delivered intravenously immediate at the end of remifentanil pump finished

Other names: Sufenil

Butorphanol tartrate

Drug

Butorphanol 0.01 mg/kg delivered intravenously immediate at the end of remifentanil pump finished

Other names: Nuoyung

Primary outcomes

  1. VAS ratings of pain

    Time frame: 0 min after awake from anesthesia; 5,10,15,20 and 30min after awake from anesthesia

Secondary outcomes

  1. Hemodynamics of patients

    Time frame: 30min before operation; every 10min during operation; 5,10,15,20,30 and 60min after operation

  2. Sedative ratings with VAS system

    Time frame: 0,5,10,15,25,45 and 60min after awake from anesthesia

  3. Overall VAS satisfaction ratings

    Time frame: 1 h after operation

  4. Blood cortisol and β-endorphin levels

    Time frame: 0, 10min before the end of surgeries, 10min, 1h and 6h after operation

  5. Side effects

    Time frame: 1 h after operation

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia in Gynecological Laparoscopic Surgeries

Acronym: CARAN

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 20, 2008
Registry last updated
Mar 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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