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

"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.

Study Overview

• Status: Completed
• Conditions: Shivering
• Intervention / Treatment: Drug: Dexmedetomidine; Other: Normal Saline (Placebo)

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Liaquat National Hospital and Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; Received intravenous dexmedetomidine	Drug: Dexmedetomidine; intravenous dexmedetomidine given in form of 100ml infusion over 10 minutes
Placebo Comparator: Control group; control group receive normal saline	Other: Normal Saline (Placebo); control group receive normal saline as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shivering	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	3 minutes following infusion

Collaborators and Investigators

• Sponsor: Liaquat National Hospital & Medical College
• Investigators: Principal Investigator: Ghulam Fatima kharl, Liaquat National Hospital and Medical College

Publications and helpful links

Helpful Links

• Kumar S, Choudhury B, Varikasuvu SR, Singh H, Kumar S, Lahon J, et al. A Systematic Review and Meta-analysis of Efficacy and Safety of Dexmedetomidine Combined With Intrathecal Bupivacaine Compared to Placebo. Cureus. 2022;14(12):e32425.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2023
• Primary Completion (Actual): June 15, 2024
• Study Completion (Actual): June 21, 2024

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Estimated): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: shivering, dexmedetomidine, neuraxial anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: Liaquat National Hospital 1234; Dr ghulam fatima (Other Identifier: liaquat national hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Reasons of why individual participant data (IPD) may not be shared:

1. *Patient confidentiality*: Sharing IPD could compromise patient confidentiality
2. *Informed consent*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns.
3. *Data storage and security*: Sharing IPD requires ensuring the security and integrity of the data, which can be a significant technical challenge.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No