Ain Shams University
Cairo, Egypt
NCT Number: NCT06513806
Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
Looking for future studies?
Notify Me18 year–45 year
Female
Interventional
Phase 4
Cairo, Egypt
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
will receive granisetron 3 mg iv bolus
will receive pethidine 25 mg iv bolus
Time frame: perioperatively/periprocedurally
If shivering occurs the degree of Shivering will be classified as:
assessment of tested drugs in treating post spinal shivering in patients who undergone cesarean delivery and have been treated with either granisetron or pethidine
Time frame: 12 hours postoperative
pain scores by VAS (visual analogue scale) which is from 0-10 , 0 no Pain and 10 worst pain
Time frame: 12 hours postoperative
incidence of postoperative complications: nausea, vomiting
Ain Shams University
Other
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.
NCT03541798
Anesthesia; Adverse Effect, Spinal and Epidural, Hip Arthropathy
Ankara, Altındag, Turkey (Türkiye)
View Trial DetailsNCT02477501
Anesthesia; Adverse Effect, Spinal and Epidural, Cardiovascular Diseases
Tunis, Tunisia
View Trial DetailsNCT02271477
Anesthesia; Adverse Effect, Spinal and Epidural, Edema
Bellinzona, Switzerland
View Trial DetailsNCT01845389
Anesthesia; Adverse Effect, Spinal and Epidural
Cairo, Egypt
View Trial Details