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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00738192
Acronym
CARAN
Enrollment
150
Registered
2008-08-20
Start date
2008-07-31
Completion date
2009-03-31
Last updated
2009-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Postoperative analgesia, Opioids, Laparoscopic surgery

Brief summary

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.

Interventions

DRUGFentanyl citrate

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

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

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

Sponsors

Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
VAS ratings of pain0 min after awake from anesthesia; 5,10,15,20 and 30min after awake from anesthesia

Secondary

MeasureTime frame
Hemodynamics of patients30min before operation; every 10min during operation; 5,10,15,20,30 and 60min after operation
Sedative ratings with VAS system0,5,10,15,25,45 and 60min after awake from anesthesia
Overall VAS satisfaction ratings1 h after operation
Blood cortisol and β-endorphin levels0, 10min before the end of surgeries, 10min, 1h and 6h after operation
Side effects1 h after operation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026