Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intrathecal Mg in Gynecologic Laparoscopic Surgeries.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671227
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
khaled salah mohamed, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gynecologic Laparoscopic Surgery Drug: intrathecal Mg sulfate. Drug: intrathecal bupivacaine 15 mg. Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Surgeon Satisfaction and Postoperative Pain in Gynecologic Laparoscopic Surgeries.
Study Start Date : August 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. postoperative pain management (VAS score). [ Time Frame: postoperative for 6 hours. ]
    Visual Analog Scale (VAS score).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671227


Locations
Layout table for location information
Egypt
Asiut university hospital
Asiut, Egypt, 71515
Sponsors and Collaborators
Assiut University
Layout table for additonal information
Responsible Party: khaled salah mohamed, lecturer of anaesthesia and ICU, Assiut University
ClinicalTrials.gov Identifier: NCT02671227    
Other Study ID Numbers: intrathecal Mg in gyne. lap.
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents