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A single-center, prospective, randomized, controlled, double-blind study of the effect of butorphanol combined with ondansetron on itching caused by intrathecal injection of morphine in cesarean section

A single-center, prospective, randomized, controlled, double-blind study of the effect of butorphanol combined with ondansetron on itching caused by intrathecal injection of morphine in cesarean section

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050772
Enrollment
Unknown
Registered
2021-09-04
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

itching caused by intrathecal injection of morphine in cesarean section

Interventions

Control group:intravenously injects 4ml of normal saline twice
Butorphanol group:intravenously injects 4ml of 1mg butorphanol and 4ml of normal saline
Ondansetron group:intravenously injects 4ml of 8mg ondansetron and 4ml of normal saline were injected intravenously
Combination group:intravenously injects 4ml of 1mg butorphanol and 4ml of 8mg ondansetron

Sponsors

General Hospital of Northern Theater Command
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective cesarean section at the General Hospital of the Northern Theater Command; 2. Voluntarily participate and sign the informed consent; 3. ASA II; 4. Term pregnancy; 5. Aged 20-40 years; 6. No contraindications for spinal anesthesia; 7. Perform subarachnoid block and block successfully (the plane reaches T6 and above); 8. Morphine 200ug was used for postoperative analgesia during subarachnoid block.

Exclusion criteria

Exclusion criteria: 1. Mental illness, unable to communicate normally, refusing to participate in the trial, or unable to give informed consent; 2. Severe cardio-cerebral and lung diseases, including unstable angina, myocardial infarction, ventricular dysfunction, and increased intracranial pressure; 3. Severe pregnancy-induced hypertension; 4. Gastrointestinal diseases, including gastrointestinal obstruction; 5. Liver insufficiency; 6. Motion sickness and obvious history of nausea and vomiting during pregnancy; 7. Preoperative skin allergy, acute and chronic pruritus; 8. Opioid analgesics and sedatives have been used recently; 9. Use antipruritic drugs before surgery; 10. Related drug allergies; 11. Subarachnoid block failure or poor anesthesia effect.

Design outcomes

Primary

MeasureTime frame
Occurrence of itching;

Secondary

MeasureTime frame
Analgesia score;Sedation score;

Countries

China

Contacts

Public ContactCao Huijuan

General Hospital of Northern Theater Command

caohuijuan1212@sina.com+86 13309880882

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026