Clinical trial NCT06711913: Role of Intravenous Dexmedetomidine in Reducing Shivering After Shivering Cesarean Section Due to Spinal Anesthesia
Official title: Effects of Intravenous Dexmedetomidine on Shivering After Cesarean Delivery Under Neuraxial Anesthesia - A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Shivering
Keywords: shivering, dexmedetomidine, neuraxial anesthesia
Lead sponsor: Liaquat National Hospital & Medical College
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Shivering
timeFrame: 3 minutes following infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Liaquat National Hospital and Medical College
state: Sindh
Study officials:
affiliation: Liaquat national hospital and medical college
name: Ghulam Fatima kharl
role: PRINCIPAL_INVESTIGATOR
References: