Effect of Prophylactic Ondansetron on the Incidence of Spinal-anesthesia-induced Shivering and Hypotension in Elective Cesarean Sections

Effect of Prophylactic Ondansetron on the Incidence of Spinal-anesthesia-induced Shivering and Hypotension in Elective Cesarean Sections: A Prospective, Randomized, Placebo-Controlled, Double-Blind Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20200825001

Enrollment

Unknown

Registered

2020-08-25

Start date

2019-05-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spinal anesthesia induced hypotension spinal anesthesia induced shivering bradycardia nausea vomiting headache pain pruritus dizziness respiratory depression. spinal anesthesia hypotension shivering cesarean section

Interventions

The intervention group received intravenous ondansetron drug (4 mg diluted in 10 ml 0.9% saline) prior to spinal anesthesia induction,the control received only intravenous placebo (10 ml of 0.9% salin

Experimental Drug,Placebo Comparator No treatment

Ondansetron group,placebo control group

Eligibility

Sex/Gender

Female

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective cesarean sections surgery 2. American Society of Anesthesiologists (ASA) I or II classification 3. No major systemic diseases

Exclusion criteria

Exclusion criteria: 1. Pre-existing or gestational hypertension 2. History of allergy to ondansetron drug 3. Cardiovascular or cerebrovascular diseases 4. Urgent cesarean sections 5. Mothers with suspected deteriorated fetuses 6. Contraindications for spinal block 7. Thyroid disorders 8. Participant temperature > 38Â°C or < 36.5Â°C 9. Patients likely to receive intraoperative blood transfusion

Design outcomes

Primary

Measure	Time frame
Incidence spinal-anesthesia-induced Hypotension induction time,3,9,12,15 minutes intraoperatively and 5,10,15 min postoperatively hypotension is defined as systolic blood pressure lower than 100 mmHg ,Incidence spinal-anesthesia-induced shivering induction time,3,9,12,15 minutes intraoperatively and 5,10,15 min postoperatively Shivering was graded using the previously validated 5-item scale (Crossley & Mahajan, 1994; Tsai & C	—

Measure

Time frame

Incidence spinal-anesthesia-induced Hypotension induction time,3,9,12,15 minutes intraoperatively and 5,10,15 min postoperatively hypotension is defined as systolic blood pressure lower than 100 mmHg ,Incidence spinal-anesthesia-induced shivering induction time,3,9,12,15 minutes intraoperatively and 5,10,15 min postoperatively Shivering was graded using the previously validated 5-item scale (Crossley & Mahajan, 1994; Tsai & C

—

Secondary

Measure	Time frame
perioperative bradycardia nausea,vomiting,headache,pain,pruritus,dizziness respiratory depression. induction time,3,9,12,15 minutes intraoperatively and 5,10,15 min postoperatively pain and headache measured using the numerical rating scale (0-10),Nausea and vomiting 0-5 scale	—

Contacts

Public ContactAhmad Salahat

An-Najah National University

rn.salahat@hotmail.com00972598557748

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

Effect of Prophylactic Ondansetron on the Incidence of Spinal&#45;anesthesia&#45;induced Shivering and Hypotension in Elective Cesarean Sections