Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate

January 3, 2017 updated by: MOHAMED F. MOSTAFA, Assiut University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Magnesium sulfate (MgSO4) has anti-shivering effects. Moreover, it has potential neuroprotective effects and may enhance neuroprotection against the effects of hypothermia. Intrathecal MgSO4 administration provides effective perioperative analgesia and can prolong the period of anesthesia and sensory blockade without any additional side-effects. However, most of the research on the role of MgSO4 in the prevention of shivering has focused on intravenous infusion of this drug. Few clinical trials have examined the effect of adding intrathecal MgSO4 to anesthetic agents such as bupivacaine to suppress anesthesia-related shivering in patients. Similar to infusion studies, we hypothesized that the addition of intrathecal injection of MgSO4 to bupivacaine would improve perioperative shivering in female patients undergoing elective caesarean section. Few previous studies evaluated neuroaxial anti-shivering effects of intrathecal magnesium and none evaluated the anti-shivering effect of intrathecal MgSO4. Therefore, we elected to use the lowest dosage (25 mg MgSO4) that was formerly utilized for investigation of analgesic effects.

Magnesium sulphate is an intracellular cation with various physiologic functions such as enzyme activation, nerve signal conduction, protein synthesis and vasomotor tonicity regulation. Magnesium sulphate has been used in various clinical situations including preeclampsia, tocolysis, arrhythmias, myocardial ischemia, bronchial asthma and postoperative shivering.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 38⁰ C.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group M
2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally
Drug: MgSo4

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.
Active Comparator: Group P
2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally
Drug: Placebo

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Shivering Score
Time Frame: 2 hours
shivering will be recorded in the recovery room for 2 hours
2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Pain Score
Time Frame: 2 hours
analgesics will be given if visual analogue score ≥ 4
2 hours
Complications
Time Frame: 2 hours
percentage of patients with any complications will be recorded
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Zain E. Hassan, MD, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 4, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Shivering, MgSO4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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