Intravenous Granisetron Vs Dexmedetomidine on Postspinal in the Cesarean Section.

Minia University

Status: Invitation-only

Conditions: Postspinal Shivering

Treatments: Drug: Granisetron; Other: Placebo; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06762860

postspinal shivering

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 3 patient groups, including a placebo group

Dexmedetomidine Group

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Granisetron Group

Active Comparator group

Description:

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

Treatment:

Drug: Granisetron

Control Group

Placebo Comparator group

Description:

Patients in this group will receive 10 ml normal saline 0.9% over 10 minutes immediately after clamping of the cord (placebo control group).

Treatment:

Other: Placebo