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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06711913
Enrollment
60
Registered
2024-12-02
Start date
2023-12-21
Completion date
2024-06-21
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shivering

Keywords

shivering, dexmedetomidine, neuraxial anesthesia

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.

Interventions

DRUGDexmedetomidine

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

OTHERNormal Saline (Placebo)

control group receive normal saline as placebo

Sponsors

Liaquat National Hospital & Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Shivering3 minutes following infusionCrossley 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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026