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

L

Liaquat National Hospital & Medical College

Status and phase

Completed
Phase 2

Conditions

Shivering

Treatments

Drug: Dexmedetomidine
Other: Normal Saline (Placebo)

Study type

Interventional

Funder types

Other

Identifiers

NCT06711913
Liaquat National Hospital 1234
Dr ghulam fatima (Other Identifier)

Details and patient eligibility

About

"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.

Full 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.

Enrollment

60 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

Intervention group
Active Comparator group
Description:
Received intravenous dexmedetomidine
Treatment:
Drug: Dexmedetomidine
Control group
Placebo Comparator group
Description:
control group receive normal saline
Treatment:
Other: Normal Saline (Placebo)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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