Intrathecal DEX With Bupivacaine Inpost-spinal Shivering After CS.

NCT06942000 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: MSC/AZAST/API029/2/239/1/2025.
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Conditions

Post Spinal Anesthesia Shivering

Keywords

Cesarean Section; Dexmedetomidine; Intrathecal Anesthesia; Shivering

Outcome Measures

Primary Outcomes (1)

• efficacy on the incidence and severity of shivering associated with spinal anesthesia.

  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 Outcomes (1)

• incidence of adverse effects

  Immediately after spinal anesthesia, and within 90 minutes later

Study Arms (3)

Group D3: (dexmedetomidine 3mcg group)

ACTIVE COMPARATOR

parturients will receive spinal anesthesia consisting of 2ml (10mg) of 0.5% hyperbaric bupivacaine .

Drug: dexmedetomidine 3mcg group

Group D5: (dexmedetomidine 5mcg group)

ACTIVE COMPARATOR

parturients will receive spinal anesthesia consisting of 2ml (10mg) of 0.5% hyperbaric bupivacaine .

Drug: dexmedetomidine 5mcg

Group C: (Control group)

PLACEBO COMPARATOR

parturients will receive spinal anesthesia consisting of 2 ml (10 mg) of 0.5% hyperbaric bupivacaine.

Drug: preservative-free 0.9% saline.

Interventions

dexmedetomidine 3mcg group DRUG

3mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.

Group D3: (dexmedetomidine 3mcg group)

dexmedetomidine 5mcg DRUG

5mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.

Group D5: (dexmedetomidine 5mcg group)

preservative-free 0.9% saline. DRUG

(0.5 ml) preservative-free 0.9% saline

Group C: (Control group)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Full-term pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (2)

Faculty of Medicine, Al-Azhar University, Assiut, Egypt

Asyut, 71523, Egypt

Location

Mohamed Ali Mahmoud

Asyut, 71523, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Population Groups; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Demography; Population Characteristics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Osama H. Ahmed, MD

  Professor at Faculty of Medicine, Al-Azhar University, Assiut, Egypt

  STUDY DIRECTOR

Central Study Contacts

Mohamed A. Mahmoud, MD

CONTACT

01002538320; mohamedali.226@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double (Participant, Care Provider)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, intensive care and pain management

Model Details: 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 Record Dates

• First Submitted: April 8, 2025
• First Posted: April 24, 2025
• Study Start: May 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)