Skip to main content
OpenTrials
Completed

NCT Number: NCT06711913

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

"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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Liaquat National Hospital and Medical College

Karachi, Sindh, Pakistan

About this study

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:

  • *Hypothermia*: Spinal anesthesia can cause a decrease in core body temperature, leading to shivering.
  • *Sympathetic blockade*: Spinal anesthesia blocks sympathetic nerve fibers, causing vasodilation and decreased blood flow to the extremities.
  • *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:

  • *Decreased shivering intensity*: Dexmedetomidine reduces the severity of shivering, making patients more comfortable.
  • *Increased core body temperature*: Dexmedetomidine helps to maintain core body temperature, reducing the likelihood of hypothermia-induced shivering.
  • *Reduced oxygen consumption*: By decreasing shivering, dexmedetomidine reduces oxygen consumption, which is beneficial for patients with cardiovascular or respiratory disease.
  • *Improved patient comfort*: Dexmedetomidine's sedative and anxiolytic effects contribute to improved patient comfort and satisfaction.
  • *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:

  • *Alpha-2 adrenergic receptors*: Dexmedetomidine activates alpha-2 adrenergic receptors, which decreases sympathetic outflow and reduces shivering.
  • *Hypothalamic thermoregulation*: Dexmedetomidine may affect the hypothalamus, the body's thermoregulatory center, to reduce shivering and maintain core body temperature.
  • *Spinal cord mechanisms*: Dexmedetomidine may also act on the spinal cord to reduce shivering, possibly by inhibiting the release of excitatory neurotransmitters.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

intravenous dexmedetomidine given in form of 100ml infusion over 10 minutes

Normal Saline (Placebo)

Other

control group receive normal saline as placebo

Primary outcomes

  1. Shivering

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Liaquat National Hospital & Medical College

Other

Registry information

Official study title

Effects of Intravenous Dexmedetomidine on Shivering After Cesarean Delivery Under Neuraxial Anesthesia - A Randomized Control Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.