Role of Intravenous Dexmedetomidine in Reducing Shivering After Shivering Cesarean Section Due to Spinal Anesthesia

Phase 2

Completed

• Conditions: Shivering
• Interventions: Drug: Dexmedetomidine; Other: Normal Saline (Placebo)

• Registration Number: NCT06711913
• Lead Sponsor: Liaquat National Hospital & Medical College

Brief Summary

"After spinal anesthesia, some patients may experience shivering, which can be uncomfortable and even lead to complications. Dexmedetomidine is a medication that can help prevent or reduce this shivering.

Dexmedetomidine helps to:

1. Reduces shivering and discomfort.

2. Improves patient comfort and satisfaction.

3. Regulates body temperature.

4. Safe and effective.

Detailed Description

Post-spinal shivering is a common complication that occurs in 40-65% of patients undergoing spinal anesthesia. It is characterized by involuntary, rhythmic muscle contractions that can lead to discomfort, anxiety, and increased oxygen consumption.

The exact mechanisms underlying post-spinal shivering are not fully understood, but several factors contribute to its development:

1. \*Hypothermia\*: Spinal anesthesia can cause a decrease in core body temperature, leading to shivering.

2. \*Sympathetic blockade\*: Spinal anesthesia blocks sympathetic nerve fibers, causing vasodilation and decreased blood flow to the extremities.

3. \*Increased oxygen consumption\*: Shivering increases oxygen consumption, which can be detrimental in patients with pre-existing cardiovascular or respiratory disease.

\*Effects of Dexmedetomidine on Post-Spinal Shivering\*

Dexmedetomidine, an alpha-2 adrenergic agonist, has been shown to effectively reduce post-spinal shivering. Its effects include:

1. \*Decreased shivering intensity\*: Dexmedetomidine reduces the severity of shivering, making patients more comfortable.

2. \*Increased core body temperature\*: Dexmedetomidine helps to maintain core body temperature, reducing the likelihood of hypothermia-induced shivering.

3. \*Reduced oxygen consumption\*: By decreasing shivering, dexmedetomidine reduces oxygen consumption, which is beneficial for patients with cardiovascular or respiratory disease.

4. \*Improved patient comfort\*: Dexmedetomidine's sedative and anxiolytic effects contribute to improved patient comfort and satisfaction.

5. \*Reduced need for other anti-shivering interventions\*: Dexmedetomidine's effectiveness in reducing post-spinal shivering may reduce the need for other interventions, such as meperidine, clonidine, or forced-air warming.

Dexmedetomidine's anti-shivering effects are thought to be mediated by its actions on the following mechanisms:

1. \*Alpha-2 adrenergic receptors\*: Dexmedetomidine activates alpha-2 adrenergic receptors, which decreases sympathetic outflow and reduces shivering.

2. \*Hypothalamic thermoregulation\*: Dexmedetomidine may affect the hypothalamus, the body's thermoregulatory center, to reduce shivering and maintain core body temperature.

3. \*Spinal cord mechanisms\*: Dexmedetomidine may also act on the spinal cord to reduce shivering, possibly by inhibiting the release of excitatory neurotransmitters.

Study Timeline

• Study Start: 2023-12-21
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-21
• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Elective Cesarean section
• Age limit 18 to 35 years
• ASA II

Exclusion Criteria

• Emergency cesarean delivery
• hypersensitive to dexmedetomidine
• Pateint with hear, renal, or hepatic diseases requiring follow up
• Pre-eclemptic pateint
• Patient with GA
• Combined spinal epidural anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Dexmedetomidine	Received intravenous dexmedetomidine
Control group	Normal Saline (Placebo)	control group receive normal saline

Primary Outcome Measures

Name	Time	Method
Shivering	3 minutes following infusion	Crossley and Mahajan grading of intraoperative shivering Grade 0: no shivering grade 1:no visible muscle activity but piloerection, peripheral vasoconstriction, or both present grade 2: muscular activity in one muscle group grade 3: muscle activity in one than more muscle group

Trial Locations

Locations (1)

Liaquat National Hospital and Medical College; 🇵🇰 Karachi, Sindh, Pakistan