Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section

Ain Shams University

Status and phase: Completed; Phase 1

Conditions: Post Spinal Shivering

Treatments: Drug: Dexmedetomidine Injection [Precedex],,,; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT06318546

FMASU MS59/2024

Details and patient eligibility

About

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

Full 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%

Enrollment: 130 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl

Dexmedetomidine

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine Injection [Precedex],,,