Clinical trial NCT06762860: Intravenous Granisetron Vs Dexmedetomidine on Postspinal in the Cesarean Section.
Official title: The Effect of Intravenous Granisetron Versus Intravenous Dexmedetomidine on Shivering Following Spinal Anesthesia in the Cesarean Section. a Randomized Controlled Comparative Trial .
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Postspinal Shivering
Keywords: shivering after spinal anesthesia in cesarean section
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 99
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group C: Patients in this group will receive 10 ml normal saline (0.9%) over 10minutes immediately after clamping of the cord (control group).

Group D: Patients in this group will receive (0.3 ug/kg) intravenous Dexmedetomidine added to normal saline to get 10 ml of colorless solution and injected over 10 minutes after clamping of the cord.

Group G: Patients in this group will receive 3 mg intravenous Granisetron added to normal saline to get 10 ml of colorless solution and injected over 10 minutes immediately after clamping of the cord.
Primary purpose: PREVENTION

Brief summary: The Aim of this study is to investigate and compare the efficacy of intravenous Dexmedetomidine (0.3 ug/kg) versus intravenous Granisetron (3 mg) in the prevention of shivering in parturient undergoing cesarean section under spinal anesthesia.

Detailed description: Study groups:

Randomization will be done according to computer guided table with sealed closed envelopes prepared by the supervisor, All study drugs will be prepared by the supervisor. Each group will be 25 patients.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for cesarean section under spinal anesthesia.
* age : (20-45) years old.
* American Society of Anesthesia (ASA) physical status I, II.

Exclusion Criteria:

* Patient refusal.
* Contraindication to spinal anesthesia.
* BMI \> 35 kg/m².
* Impaired renal, hepatic and cardiac function.
* Thyroid disease.
* Body temperature \>38 °C or \< 36.5 °C.

Primary outcomes:
measure: The incidence and severity of post spinal shivering.
timeFrame: every 10 minutes intraoperatively and every 15 minutes postoperatively for 4 hours
Secondary outcomes:
measure: change in the basal axillary temperature.
timeFrame: preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively
measure: change in the basal mean arterial blood pressure
timeFrame: preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively.
measure: Change in the basal heart rate
timeFrame: preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively.
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minya University Faculty of Medicine
Study officials:
References: