Skip to main content
OpenTrials
Completed

NCT Number: NCT06513806

Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections

Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University

Cairo, Egypt

About this study

Shivering is known to be a frequent complication, reported in 40 to 70% of patients undergoing surgery under regional anaesthesia. Shivering is a potentially serious complication, resulting in increased metabolic rate; increased oxygen consumption (up to 100-600%) along with raised carbon dioxide (CO2) production; ventilation and cardiac output; adverse postoperative outcomes.Post cesarean section spinal shivering is frequent. It causes involuntary muscular contractions and pain. Shivering, or muscular contractions, may be moderate or severe and persist for varying lengths. Anesthesia and body temperature fluctuations may produce post-spinal shivering. Properly managing post-spinal shivering improves patient outcomes and satisfaction.

Granisetron and pethidine treat post-spinal shivering. Granisetron blocks acetylcholine, a neurotransmitter that contracts muscles. Pethidine inhibits norepinephrine. Both drugs reduce post spinal shivering. However, the efficacy of granisetron and pethidine in treating post-cesarean spinal shivering has not been adequately explored.

Patients will undergo spinal anesthesia via the administration of 2.5ml of Bupivacaine 0.5% intrathecally using a 25-gauge spinal needle. The patients will be continuously monitored for any episodes of shivering, nausea, and vomiting. Vital data of the patients will also be closely monitored including oxygen saturation, pulse rate, blood pressure, respiratory rate and temperature at 10 minutes intervals throughout the operation and the stay in the recovery room. (PACU time around 30 minutes)

If shivering occurs the degree of Shivering will be classified as:

  • 0: No shivering
  • 1: Mild fasciculations of face or neck and ECG disturbances in the absence of voluntary activity of the arms
  • 2: Visible tremor involving more than one muscle group
  • 3: Gross muscular activity involving the entire body

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • elective for caesarian section presence of post-spinal shivering, defined as involuntary muscle contractions occurring within operative and early recovery period after cesarean delivery.
  • Age 18 - 45

Exclusion criteria

  • Inability to provide informed consent.
  • Previous allergies or sensitivities to granisetron or pethidine.
  • Current use of medications that may interact with granisetron or pethidine.
  • Presence of other conditions that may contraindicate the use of granisetron or pethidine, such as known liver or kidney disease.
  • Patients who are too short (<140 cm) or too tall (>190 cm)

Treatment and study plan

Granisetron 1 Mg/mL Intravenous Solution

Drug

will receive granisetron 3 mg iv bolus

Pethidin

Drug

will receive pethidine 25 mg iv bolus

Primary outcomes

  1. treating post spinal shivering

    Time frame: perioperatively/periprocedurally

    If shivering occurs the degree of Shivering will be classified as:

    • 0: No shivering
    • 1: Mild fasciculations of face or neck and ECG disturbances in the absence of voluntary activity of the arms
    • 2: Visible tremor involving more than one muscle group
    • 3: Gross muscular activity involving the entire body

    assessment of tested drugs in treating post spinal shivering in patients who undergone cesarean delivery and have been treated with either granisetron or pethidine

Secondary outcomes

  1. pain assessment

    Time frame: 12 hours postoperative

    pain scores by VAS (visual analogue scale) which is from 0-10 , 0 no Pain and 10 worst pain

  2. nausea, vomiting

    Time frame: 12 hours postoperative

    incidence of postoperative complications: nausea, vomiting

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2024
Registry last updated
Oct 2, 2025

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.