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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

Tracking Information
First Submitted Date  ICMJE January 24, 2016
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date January 27, 2017
Study Start Date  ICMJE August 2016
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
postoperative pain management (VAS score). [ Time Frame: postoperative for 6 hours. ]
Visual Analog Scale (VAS score).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrathecal Mg in Gynecologic Laparoscopic Surgeries.
Official Title  ICMJE Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Surgeon Satisfaction and Postoperative Pain in Gynecologic Laparoscopic Surgeries.
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gynecologic Laparoscopic Surgery
Intervention  ICMJE
  • Drug: intrathecal Mg sulfate.
    intrathecal Mg sulfate 50 mg.
  • Drug: intrathecal bupivacaine 15 mg.
    intrathecal bupivacaine 15 mg.
Study Arms  ICMJE
  • Active Comparator: intrathecal bupivacaine + Mg sulfate
    intrathecal bupivacaine 15 mg + intrathecal Mg sulfate 50 mg. in gynecologic laparoscopic surgeries.
    Interventions:
    • Drug: intrathecal Mg sulfate.
    • Drug: intrathecal bupivacaine 15 mg.
  • Active Comparator: intrathecal bupivacaine
    intrathecal bupivacaine 15 mg in gynecologic laparoscopic surgeries.
    Intervention: Drug: intrathecal bupivacaine 15 mg.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 29, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02671227
Other Study ID Numbers  ICMJE intrathecal Mg in gyne. lap.
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party khaled salah mohamed, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP