Intrathecal Fentanyle Versus Dexamethasone in Gynacological Laparoscopic Surgeries

March 15, 2021 updated by: Rasha Hamed, Assiut University

Intrathecal Fentanyle Versus Dexamethasone in Patients Under Going Gynacological Laparoscopic Surgeries

Laparoscopy was first introduced to the medical field of in the middle of the last century. It revolutionized the surgical interventions; it reduced the total medical expenditures and hastened postoperative recovery . General anaesthesia (GA) was considered the only anesthetic technique suitable for laparoscopic interventions, and several myths and facts prevented regional anaesthesia (RA) implementation. Respiratory and Cardiovascular impairment were the main aspects of concern which are thought to be best controlled by GA

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA I, II
  • elective gynacological laparoscopic surgery

Exclusion Criteria:

  • patient refusal
  • chronic kidney and hepatic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: control group
Drug: saline
normal saline will be mixed with bupivacaine intrathecally
ACTIVE_COMPARATOR: fentanyle group
Drug: intrathecal fentanyle
25 mic fentanyle added to heavy bupivacaine for spinal anesthesia
ACTIVE_COMPARATOR: dexamethasone group
Drug: dexamethasone
8 mg dexamethasone give intrathecally for spinal anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative pain
Time Frame: 60 minutes
pain measured by VAS score =from 0 to 10 0-3 is mild pain 3-6 moderate pain 6-10 sever pain
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

September 1, 2020

Study Completion (ACTUAL)

September 1, 2020

Study Registration Dates

First Submitted

February 27, 2021

First Submitted That Met QC Criteria

February 27, 2021

First Posted (ACTUAL)

March 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13700331

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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