Intrathecal DEX With Bupivacaine Inpost-spinal Shivering After CS.

Phase 3

Not yet recruiting

• Conditions: Post Spinal Anesthesia Shivering
• Interventions: Drug: dexmedetomidine 3mcg group; Drug: dexmedetomidine 5mcg; Drug: preservative-free 0.9% saline.

• Registration Number: NCT06942000
• Lead Sponsor: Al-Azhar University

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

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-20
• Last Update Submitted: 2025-04-20
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24
• Study Start: 2025-05-01
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
efficacy 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	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.

Secondary Outcome Measures

Name	Time	Method
incidence of adverse effects	Immediately after spinal anesthesia, and within 90 minutes later	the incidence of adverse effects, including nausea, vomiting, bradycardia, hypotension and sedation.

Trial Locations

Locations (2)

Faculty of Medicine, Al-Azhar University, Assiut, Egypt; 🇪🇬 Assiut, Egypt

Mohamed Ali Mahmoud; 🇪🇬 Assiut, Egypt