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Evaluation of Pain Reduction after surgery in patients undergoing Video Surgery for Gallbladder Removal under General Anesthesia with Initiation of Anesthesia using Sufentanil or Fentanyl, comparative, prospective, randomized clinical study

Evaluation of Postoperative Analgesia in patients undergoing Laparoscopic Cholecystectomy under General Anesthesia with Anesthetic Induction performed using Sufentanil or Fentanyl, comparative, prospective and randomized clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-2xg3qct
Enrollment
Unknown
Registered
2023-07-27
Start date
2022-03-16
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

cholelithiasis

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial. A total of 40 people who meet the eligibility criteria are probabilistically allocated to one or the other intervention group usi
E03.091

Sponsors

Hospital Universitário da Universidade Federal de Sergipe (UFS)
Lead Sponsor
Vila Velha Hospital
Collaborator

Eligibility

Sex/Gender
Male
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients physical status ASA 1, 2 and 3; from 18 years to 85 years; undergoing laparoscopic cholecystectomy under general anesthesia

Exclusion criteria

Exclusion criteria: ASA 4 patients; patients undergoing another associated anesthetic technique such as spinal or epidural anesthesia; surgeries that require other surgical procedures in addition to videolaparoscopy cholecystectomy; cholecystectomy surgeries that require conversion to conventional open surgery; patients with a history of allergic reactions to the use of any of the medications present in the protocol of this study

Design outcomes

Primary

MeasureTime frame
Postoperative analgesia. Evaluated through the level of pain reported by patients according to a verbal numerical scale from zero to ten (zero indicating no pain and ten a maximum pain level) and by measuring the consumption of rescue analgesic (morphine) by patients. Intraoperative remifentanil consumption.

Secondary

MeasureTime frame
Possible adverse effects related to the administration of sufentanil and fentanyl in the induction of general anesthesia. Evaluating the time of anesthetic awakening and the presence of nausea, vomiting, pruritus, drowsiness and respiratory depression.

Countries

Brazil

Contacts

Public ContactDaniel Menezes

Hospital Universitário da Universidade Federal de Sergipe (UFS)

carvalho.menezes@ebserh.gov.br+55(79)999870979

Outcome results

None listed

Source: REBEC (via WHO ICTRP)