Intrathecal Mg in Gynecologic Laparoscopic Surgeries.

Gynecologic Laparoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671227
• Other study ID #: intrathecal Mg in gyne. lap.
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2016
• Last updated: January 26, 2017
• Start date: August 2016
• Est. completion date: January 2017

Study information

• Verified date: August 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Laparoscopic Surgery

Intervention

Drug:
• intrathecal Mg sulfate.
intrathecal Mg sulfate 50 mg.
• intrathecal bupivacaine 15 mg.
intrathecal bupivacaine 15 mg.

Locations

Country	Name	City	State
Egypt	Asiut university hospital	Asiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgeon satisfaction (scale from 1 to 10) .	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	postoperative pain management (VAS score).	Visual Analog Scale (VAS score).	postoperative for 6 hours.