Intrathecal DEX With Bupivacaine Inpost-spinal Shivering After CS.

NCT ID: NCT06942000

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-12-30

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

Conditions

Post Spinal Anesthesia Shivering

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group D3: (dexmedetomidine 3mcg group)

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

Group Type: ACTIVE_COMPARATOR

dexmedetomidine 3mcg group

Intervention Type: DRUG

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

Group D5: (dexmedetomidine 5mcg group)

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

Group Type: ACTIVE_COMPARATOR

dexmedetomidine 5mcg

Intervention Type: DRUG

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

Group C: (Control group)

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

Group Type: PLACEBO_COMPARATOR

preservative-free 0.9% saline.

Intervention Type: DRUG

(0.5 ml) preservative-free 0.9% saline

Interventions

dexmedetomidine 3mcg group

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

Intervention Type: DRUG

dexmedetomidine 5mcg

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

Intervention Type: DRUG

preservative-free 0.9% saline.

(0.5 ml) preservative-free 0.9% saline

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ali Mahmoud

Lecturer of anesthesia, intensive care and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Osama H. Ahmed, MD

Role: STUDY_DIRECTOR

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

Locations

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

Asyut, , Egypt

Mohamed Ali Mahmoud

Asyut, , Egypt

Countries

Egypt

Central Contacts

Mohamed A. Mahmoud, MD

Role: CONTACT

mohamedali.226@azhar.edu.eg

01002538320 ext. 002

Facility Contacts

Mohamed A. Mahmoud, MD

Role: primary

mohamedali.226@azhar.edu.eg

01002538320 ext. 002

Osama M. Fathy, ( M.B.B.CH)

Role: backup

mohamedali.226@azhar.edu.eg

01002538320 ext. 002

Mohamed A Mahmoud

Role: primary

mohamedali.226@azhar.edu.eg

01002538320

Other Identifiers

MSC/AZAST/API029/2/239/1/2025.

Identifier Type: -

Identifier Source: org_study_id