Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-01-01 @ 6:35 AM
Study NCT ID:
NCT06513806
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2024-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: