Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section

Phase 1

Completed

• Conditions: Post Spinal Shivering
• Interventions: Drug: Fentanyl; Drug: Dexmedetomidine Injection [Precedex],,,

• Registration Number: NCT06318546
• Lead Sponsor: Ain Shams University

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

Detailed Description

A.Preoperative settings:

All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery.

B.Intraoperative and postoperative settings:

On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted and IV Ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anaesthesia and maintenance volume of 10ml\\kg.

For each group, patients will be put in sitting position, the procedure will be performed under complete aseptic precautions, local anaesthesia will be administered by infiltration of the skin and subcutaneous tissues with 3-5 ml lidocaine 1% at L3-L4 and A 25-G needle will be used.

Both groups will be given 2.2ml {11-12 mg} hyperbaric Bupivacaine hydrochloride 0.5%

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-19
• Study Start: 2024-04-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Last Update Submitted: 2024-11-03
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• • 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.

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Exclusion Criteria

• • 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Fentanyl	This group will undergo spinal anesthesia using fentanyl (50 microgram) as adjuvant to intrathecal bupivacaine
Dexmedetomidine	Dexmedetomidine Injection [Precedex],,,	This group will undergo spinal anesthesia using dexmedetomidine (10mg) as adjuvant to intrathecal bupivacaine

Primary Outcome Measures

Name	Time	Method
Post spinal shivering	From injection to 3 hours post operative	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)

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt