Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate

NCT03008850 | Completed Phase 2 DMC

• 1 other identifier: Shivering, MgSO4
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Shivering is a common post-anesthetic complication occurring in up to 65% of patients undergoing spinal or epidural anesthesia. Shivering may interfere with electrocardiogram, blood pressure and oxygen saturation monitoring. In addition, shivering increases oxygen consumption, carbon dioxide production and metabolic rate by up to 400%. Thus, it may result in problems in patients with low cardiac and pulmonary reserves. Preventing shivering could therefore result in better postoperative outcomes or reduce the incidence of post-surgical complications.

Conditions

Cesarean Section; Shivering

Keywords

Shivering; Intrathecal; Magnesium Sulfate

Outcome Measures

Primary Outcomes (1)

• Shivering Score

  shivering will be recorded in the recovery room for 2 hours

  2 hours

Secondary Outcomes (2)

• Visual Analogue Pain Score

  2 hours

• Complications

  2 hours

Study Arms (2)

Group M

ACTIVE COMPARATOR

2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally

Drug: MgSo4

Group P

ACTIVE COMPARATOR

2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally

Drug: Placebo

Interventions

MgSo4 DRUG

Patients will be randomly allocated to one of two groups: Group (M): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally. Group(P): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally.

Group M

Placebo DRUG

Patients will be randomly allocated to one of two groups: Group (M): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally. Group(P): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally.

Group P

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 35years.
• Undergo elective cesarean section under spinal anesthesia.
• ASA physical status I-II.
• Singleton pregnancy.
• At least 38 weeks gestation.

You may not qualify if:

• Women with history of cardiac, liver or kidney diseases.
• Women with allergy to amide local anesthetics or medication included in the study.
• Women with any neurological problem.
• Any contraindication of regional anesthesia.
• Failed or insatisfactory spinal block.
• Preoperative temperature more than 38⁰ C.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

Study Officials

• Zain E. Hassan, MD

  Assiut University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: January 4, 2017
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 5, 2017

Record last verified: 2017-01

Locations

EG (1)