Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513806
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-03-22
Brief Title:
Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 outcomesPost 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 25ml of Bupivacaine 05 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 25ml of Bupivacaine 05 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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None