Remifentanil Versus Fentanyl During Laparoscopic Hysterectomy

NCT04178785 | Unknown DMC

• 1 other identifier: 0038-19-WOMC
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction- During laparoscopic procedures surgical field exposure is one of the crucial aspects for a successful surgery. Exposure can be optimized by pneumoperitoneum, positioning of the patient and muscle relaxation. The European Association for Endoscopic Surgery has recommended using the lowest intraperitoneal pressure allowing adequate exposure of the operative field rather than using a routine pressure. A way to lower intraabdominal pressure during laparoscopic procedures is to employ a deeper level of neuromuscular blockade. Intravenous (IV) opioids such as fentanyl and remifentanil are commonly used to provide analgesia and supplement sedation during general anesthesia. In terms of analgesia, management of intraoperative stress, remifentanil exhibits similar effects to fentanyl in adult healthy volunteers and surgical patients. In clinical practice, if the surgeon asks for relaxation toward the end of the surgery, then many anesthesiologists will increase the dose of the IV opioids. In our experience the use of remifentanil achieves a better muscle relaxation and surgical space exposure with a lower intraabdominal pressure and less need for a neuromuscular blockage as compared to fentanyl. Thus, the investigators aimed to compare the use of fentanyl versus remifentanil during laparoscopic hysterectomy. Because surgical complications due to inadequate exposure are a rare event, the typical way to study this issue is to use surgeon's satisfaction score.

Conditions

Anesthesia

Keywords

laparoscopic; remifentanil; fentanyl; hysterectomy

Outcome Measures

Primary Outcomes (2)

• Surgical space conditions with modification of a 4-point scale. AT TIME OF COLPOTOMY

  1. grade 1 (optimal) = optimal surgical space conditions; 2. grade 2 (good) = nonoptimal conditions, but an intervention was not considered; 3. grade 3 (acceptable) = an intervention was considered to improve surgical space; 4. grade 4 (poor) = inadequate conditions and an intervention was necessary to ensure acceptable surgical space.

  through study completion, an average of 1 year

• Surgical space conditions with modification of a 4-point scale. AT THE END OF SURGERY

  1\. grade 1 (optimal) = optimal surgical space conditions;

  through study completion, an average of 1 year

Secondary Outcomes (1)

• surgical space conditions on a numeric rating scale (NRS)

  through study completion, an average of 1 year

Study Arms (2)

REMIFENATIL

ACTIVE COMPARATOR

Prospective, single-center single blind randomized controlled trial. Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. A blocked randomization scheme will be created using a computer-generated list of random numbers.

Drug: Remifentanil

FENTANYL

NO INTERVENTION

Prospective, single-center single blind randomized controlled trial. Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. A blocked randomization scheme will be created using a computer-generated list of random numbers.

Interventions

Remifentanil DRUG

Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio.

REMIFENATIL

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18
• scheduled for laparoscopic hysterectomy

You may not qualify if:

• known allergy to medications that are included in the trial, severe renal disease or impaired liver function

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson medical center

Holon, Israel

RECRUITING

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

MIchal De Wolf

CONTACT

9725028346; michald@wmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: November 26, 2019
• Study Start: October 22, 2019
• Primary Completion: October 22, 2020
• Study Completion: November 1, 2020
• Last Updated: November 26, 2019

Record last verified: 2019-11

Locations

IL (1)