Intrathecal Mg in Gynecologic Laparoscopic Surgeries.

January 26, 2017 updated by: khaled salah mohamed, Assiut University

Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Surgeon Satisfaction and Postoperative Pain in Gynecologic Laparoscopic Surgeries.

The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction and postoperative pain in gynecologic laparoscopic surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction, patient satisfaction and postoperative pain in gynecologic laparoscopic surgeries.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

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
      • Asiut, Egypt, 71515
        • asiut university hospital

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female patient.
  • more than 18 years.
  • undergoing elective gynecologic laparoscopic surgeries.

Exclusion Criteria:

  • allergy to local anesthesia.
  • contraindication to spinal anesthesia.
  • Significant cardiac, liver or renal dysfunction.
  • Inability to informed consent

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intrathecal bupivacaine + Mg sulfate
intrathecal bupivacaine 15 mg + intrathecal Mg sulfate 50 mg. in gynecologic laparoscopic surgeries.
Drug: intrathecal Mg sulfate.
intrathecal Mg sulfate 50 mg.
Drug: intrathecal bupivacaine 15 mg.
intrathecal bupivacaine 15 mg.
Active Comparator: intrathecal bupivacaine
intrathecal bupivacaine 15 mg in gynecologic laparoscopic surgeries.
Drug: intrathecal bupivacaine 15 mg.
intrathecal bupivacaine 15 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgeon satisfaction (scale from 1 to 10) .
Time Frame: intraoperative (from beginning of the gynecologic laparoscopic procedure till the end of the procedure).
surgeon satisfaction (scale from 1 to 10) as 1 is worst and 10 is best.
intraoperative (from beginning of the gynecologic laparoscopic procedure till the end of the procedure).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain management (VAS score).
Time Frame: postoperative for 6 hours.
Visual Analog Scale (VAS score).
postoperative for 6 hours.

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

August 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 24, 2016

First Submitted That Met QC Criteria

January 29, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • intrathecal Mg in gyne. lap.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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.

Clinical Trials on Gynecologic Laparoscopic Surgery

Clinical Trials on intrathecal Mg sulfate.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe