Clinical trial NCT06513806: Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
Official title: Granisetron Versus Pethidine in Treatment of Post Spinal Shivering in Cesarean Sections
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Anesthesia; Adverse Effect, Spinal and Epidural
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: treating post spinal shivering
timeFrame: perioperatively/periprocedurally
Secondary outcomes:
measure: pain assessment
timeFrame: 12 hours postoperative
measure: nausea, vomiting
timeFrame: 12 hours postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: Ayman M Kamaly, MD
role: STUDY_CHAIR
affiliation: Ain Shams University
name: David S Said, Msc
role: PRINCIPAL_INVESTIGATOR
References: