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A randomized controlled trial on the anxiolytic effect of butorphanol in patients with anxiety before cesarean section

A randomized controlled trial on the anxiolytic effect of butorphanol in patients with anxiety before cesarean section

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040524
Enrollment
Unknown
Registered
2020-12-01
Start date
2020-11-20
Completion date
Unknown
Last updated
2021-03-08

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

Conditions

Intraoperative anxiety

Interventions

Group of Butorphanol:Intravenous infusion corresponds to the dose of butorphanol 100 ml
Saline group:Intravenous drip of normal saline 100ML

Sponsors

henzhen Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Patients with severe preoperative anxiety (the Amsterdam APAIS score of preoperative anxiety is greater than 10) will be the subjects; 2. All patients need to sign an informed consent form to become a subject; 3. During the pre-anaesthesia visit, all participants received a complete explanation of the numerical rating scale (NRS) scores in the study protocol; 4. ASA I-II grade, 18 to 50 years old patients undergoing cesarean section.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to opioids, propofol, non-steroidal anti-inflammatory drugs, etc.; 2. Those with a history of chronic pain and mental disorders; 3. Take antidepressants, antipsychotics, tranquilizers, antiepileptics, drug addicts, opioid addicts within six months; 4. The operation time exceeds 4 hours or the bleeding volume is more than 500ML; 5. Intraoperative use of sedative analgesics other than butorphanol; 6. Pregnancy is complicated, including: preeclampsia, diabetes, hypothyroidism and Hyperthyroidism, chronic obstructive pulmonary disease, valvular heart disease, upper respiratory tract infection or sinus obstruction, mid-to-recent medical history or inner ear disease or surgery, and history of asthma.

Design outcomes

Primary

MeasureTime frame
Digital anxiety score;

Countries

China

Contacts

Public ContactXiaoli Liu

Shenzhen Maternal and Child Health Hospital

463581198@qq.com+86 13684966090

Outcome results

None listed

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