|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03008850 |
|
Date of registration:
|
27/12/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate
|
|
Scientific title:
|
Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate |
|
Date of first enrolment:
|
June 2015 |
|
Target sample size:
|
84 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03008850 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
|
|
Phase:
|
Phase 2/Phase 3
|
|
|
Countries of recruitment
|
|
Egypt
| | | | | | | |
|
Contacts
|
|
Name:
|
Zain E. Hassan, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Assiut University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Age 18 to 35years.
2. Undergo elective cesarean section under spinal anesthesia.
3. ASA physical status I-II.
4. Singleton pregnancy.
5. At least 38 weeks gestation.
Exclusion Criteria:
1. Women with history of cardiac, liver or kidney diseases.
2. Women with allergy to amide local anesthetics or medication included in the study.
3. Women with any neurological problem.
4. Any contraindication of regional anesthesia.
5. Failed or insatisfactory spinal block.
6. Preoperative temperature more than 38° C.
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Cesarean Section; Shivering
|
|
Intervention(s)
|
|
Drug: MgSo4
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Shivering Score
[Time Frame: 2 hours]
|
|
Secondary Outcome(s)
|
|
Complications
[Time Frame: 2 hours]
|
|
Visual Analogue Pain Score
[Time Frame: 2 hours]
|
|
Secondary ID(s)
|
|
Shivering, MgSO4
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|