Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section

NCT06318546 | Completed Phase 1 DMC

• 1 other identifier: FMASU MS59/2024
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will test the effects of intrathecal dexmedetomidine as adjuvant to intrathecal bupivacaine and it's direct effect in decreasing incidence of post spinal shivering in Parturients Undergoing Caesarean section

Conditions

Post Spinal Shivering

Outcome Measures

Primary Outcomes (1)

• Post spinal shivering

  will be observed following spinal anaesthesia and thereafter for 3 hours. It will be graded by a blinded observer during the intraoperative and postoperative period using the scale validated by Crossley and Mahajan \[0 = no shivering, 1 = piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 = shivering involving the whole body\]. Grades 3, and 4 shivering for at least 3 min will be considered positive, and maximum shivering will be considered if generalized shivering interfering with ECG monitoring or ability of the mother to hold the baby. Positive shivering or lower grade shivering will be treated with an IV bolus of meperidine (0.5 mg/kg)

  From injection to 3 hours post operative

Study Arms (2)

Control

ACTIVE COMPARATOR

This group will undergo spinal anesthesia using fentanyl (50 microgram) as adjuvant to intrathecal bupivacaine

Drug: Fentanyl

Dexmedetomidine

ACTIVE COMPARATOR

This group will undergo spinal anesthesia using dexmedetomidine (10mg) as adjuvant to intrathecal bupivacaine

Drug: Dexmedetomidine Injection [Precedex],,,

Interventions

Dexmedetomidine Injection [Precedex],,, DRUG

patients will receive 0.5ml (10 µg) Dexmedetomidine as an adjuvant to 2.2ml hyperbaric Bupivacaine hydrochloride 0.5%

Also known as: Precedex

Dexmedetomidine

Fentanyl DRUG

will be given 0.5 ml of one ampoule (2ml) of 100µg fentanyl (Fentanyl Hameln® 0.1mg/2ml - Sunny pharm) equivalent to 25 µg fentanyl as an adjuvant to 2.2ml hyperbaric Bupivacaine hydrochloride 0.5%

Control

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I or ASA II patients Scheduled for CS under spinal anaesthesia.
• Age 20-35 years.
• Height ≤165 cm.
• BMI ≤40.
• Procedure duration ≤ 90 minutes.

You may not qualify if:

• Patients with known neurologic and psychiatric illness.
• Contraindications for spinal anaesthesia as patient refusal, bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia.
• Spine abnormalities.
• Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency.
• Allergy to any of the drugs used in the study.
• Toxemia of pregnancy or hypertension with pregnancy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11111, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• Osama M Ragab, M.B.B.CH

  Anesthesia resident Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 19, 2024
• Study Start: April 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before 1/2025
• Access Criteria: Free

Locations

EG (1)