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ClinicalTrials.gov ID

NCT06942000

Lead Sponsor

Al-Azhar UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

40Estimated

Last Update Posted

Apr 24, 2025Actual

Start Date

May 1, 2025Estimated

Primary Completion Date

Nov 30, 2025Estimated

Completion Date

Dec 30, 2025Estimated

Official Title

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

Brief Summary

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

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

• Post Spinal Anesthesia Shivering

• dexmedetomidine 3mcg group
• dexmedetomidine 5mcg
• preservative-free 0.9% saline.

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Al-Azhar UniversityOTHER

mohamedali.226@azhar.edu.eg01002538320