Intrathecal DEX With Bupivacaine Inpost-spinal Shivering After CS. (DEX)

April 20, 2025 updated by: Mohamed Ali Mahmoud, Al-Azhar University

Efficacy of Dexmedetomidine as Adjuvant to Intrathecal Bupivacaine in Decreasing Incidence of Post-spinal Shivering in Pregnant Women Undergoing Cesarean Section.

This prospective, randomized, double-blind, placebo-controlled study to determine whether intrathecal dexmedetomidine, administered along with hyperbaric bupivacaine for covering Cesarean delivery decreases the incidence of shivering associated with spinal anesthesia

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be carried out at AL Azhar University Hospitals (Assiut) on 120 parturients belonging to ASA physical status I and II undergoing an elective cesarean delivery under spinal anesthesia procedure.

Sample size was determined by department of statistics of faculty of medicine, Al-Azhar university (Assiut).

Randomization, blinding and allocation concealment parturients will be randomly assigned into three equal groups (40 parturients for each group). According to the random number generated by computer, parturient were randomly allocated into three equal groups (40 parturients for each group) to receive either dexmedetomidine 3mcg, dexmedetomidine 5mcg or normal saline in combination with bupivacaine. The randomization sequence was placed in serially numbered opaque envelopes. Before the start of spinal anesthesia, an anesthesiologist who would not involve in the study will prepare relevant drugs according to the randomization sequence

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • 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 Contact

Study Locations

  • Egypt
      • Assiut, Egypt, 71523
        • Faculty of Medicine, Al-Azhar University, Assiut, Egypt
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohamed A. Mahmoud, MD
      • Assiut, Egypt, 71523

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Full-term pregnant women undergoing elective cesarean section under spinal anesthesia.
  • singleton pregnancy
  • Age: 20 ~ 40 years;
  • ASA physical status II ~ III;

Exclusion Criteria:

  • parturient less than 20 years and more than 40 years.
  • History of uncontrolled comorbidities, cardiac (e.g., pre-eclampsia and hypertension), respiratory, renal or hepatic disease.
  • parturients who had allergy to any medication in the study.
  • parturients with contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity)
  • parturient who has history of alcohol intake.
  • parturient received any medication likely to affect thermoregulation or Veno dilation.
  • Refusing to sign informed consent.

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
Intervention / Treatment
Active Comparator: Group D3: (dexmedetomidine 3mcg group)
parturients will receive spinal anesthesia consisting of 2ml (10mg) of 0.5% hyperbaric bupivacaine .
Drug: dexmedetomidine 3mcg group
3mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.
Active Comparator: Group D5: (dexmedetomidine 5mcg group)
parturients will receive spinal anesthesia consisting of 2ml (10mg) of 0.5% hyperbaric bupivacaine .
Drug: dexmedetomidine 5mcg
5mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.
Placebo Comparator: Group C: (Control group)
parturients will receive spinal anesthesia consisting of 2 ml (10 mg) of 0.5% hyperbaric bupivacaine.
Drug: preservative-free 0.9% saline.
(0.5 ml) preservative-free 0.9% saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy on the incidence and severity of shivering associated with spinal anesthesia.
Time Frame: Shivering will be measured at the following time points: (Immediately after spinal anesthesia, and at 5, 10, 15, 20, 30, 40, 50, 60 and 90 minutes later
evaluate the effect of intrathecal dexmedetomidine, administered as an adjunct to hyperbaric bupivacaine for Cesarean delivery, on the incidence and severity of shivering associated with spinal anesthesia.
Shivering will be measured at the following time points: (Immediately after spinal anesthesia, and at 5, 10, 15, 20, 30, 40, 50, 60 and 90 minutes later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of adverse effects
Time Frame: Immediately after spinal anesthesia, and within 90 minutes later
the incidence of adverse effects, including nausea, vomiting, bradycardia, hypotension and sedation.
Immediately after spinal anesthesia, and within 90 minutes later

Collaborators and Investigators

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

Sponsor

Al-Azhar University

Investigators

  • Study Director: Osama H. Ahmed, MD, Professor at Faculty of Medicine, Al-Azhar University, Assiut, Egypt

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 (Estimated)

May 1, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 20, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 20, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSC/AZAST/API029/2/239/1/2025.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is available with corresponding author on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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