Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section

Efficacy of Dexmedetomidine As Adjuvant to Intrathecal Bupivacaine in Decreasing Incidence of Post Spinal Shivering in Parturients Undergoing Caesarean Section

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

Study Overview

• Status: Completed
• Conditions: Post Spinal Shivering
• Intervention / Treatment: Drug: Fentanyl; Drug: Dexmedetomidine Injection [Precedex],,,

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11111
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; This group will undergo spinal anesthesia using fentanyl (50 microgram) as adjuvant to intrathecal bupivacaine	Drug: Fentanyl; 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%
Active Comparator: Dexmedetomidine; This group will undergo spinal anesthesia using dexmedetomidine (10mg) as adjuvant to intrathecal bupivacaine	Drug: Dexmedetomidine Injection [Precedex],,,; patients will receive 0.5ml (10 µg) Dexmedetomidine as an adjuvant to 2.2ml hyperbaric Bupivacaine hydrochloride 0.5%; Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Osama M Ragab, M.B.B.CH, Anesthesia resident Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine; Fentanyl
• Other Study ID Numbers: FMASU MS59/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All dana will be shared once study is completed
• IPD Sharing Time Frame: Before 1/2025
• IPD Sharing Access Criteria: Free
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No