Skip to content

The effect of perioperative application of subanaesthetic doses esketamine on postoperative pain in patients with gynecological Laparoscopic Surgery: a randomized controlled study

The effect of perioperative application of subanaesthetic doses esketamine on postoperative pain in patients with gynecological Laparoscopic Surgery: a randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063985
Enrollment
Unknown
Registered
2022-09-22
Start date
2022-09-23
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

acute postoperative pain

Interventions

Experimental group:After successful intubation, before skin incision, esketamine 50mg + normal saline was diluted to 50ml, 0.125ml/kg/h esketamine was given intravenously at a constant rate, and esket
Control group:After successful intubation, an equal volume of normal saline was given by constant-speed pump. After the operation, butorphanol 8mg+NS=100ml, background dose 1.5ml/h, Bolus 1.5ml, inter

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years; 2. ASA ?-? level; 3. BMI >=18.5 and < 30; 4. Laparoscopic gynecological surgery was planned under general anesthesia, including laparoscopic hysterectomy, laparoscopic bimadnexectomy, and laparoscopic hysteromyoma excavation, and was treated with postoperative patient-controlled intravenous analgesia pump (PCIA); 5. Hospital stay longer than 48 hours; 6. Able to read and write; 7. Informed consent can be signed.

Exclusion criteria

Exclusion criteria: 1. Diagnosed mental illness; 2. Unable to communicate before surgery due to cognitive dysfunction or language impairment; 3. A history of chronic pain or opioid abuse before surgery; 4. Postoperative admission to ICU is planned; 5. Laparotomy may be performed during the operation; 6. Patients with preoperative sleep disorder requiring oral medication; 7. A history of drug use and/or alcoholism within the last 3 months, with an average daily consumption of >2 units of alcohol (1 unit =360ml 5% alcohol beer or 45ml 40% alcohol liquor or 150ml wine; 8. Known allergy to esketamine and flurbiprofen ester; 9. Patients with any of the following contraindications for the use of Esketamine injection: (1) Patients at serious risk of elevated blood pressure or intracranial pressure; (2) Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma; (3) Patients with poorly controlled or untreated hypertension (resting systolic/diastolic blood pressure exceeding 180/110mmHg); (4) Untreated or undertreated patients with hyperthyroidism (hyperthyroidism); 10. Patients with any of the following contraindications for flurbiprofen injection: (1) Suffering from severe peptic ulcers; (2) Serious blood diseases; (3) Severe abnormal heart, liver and kidney function; (4) Severe hypertension; (5) History of aspirin asthma or previous history; (6) Eloxacin, lomefloxacin and norfloxacin are being used; 11. Pregnancy or lactation; 12. Participated in clinical research of other drugs or medical devices in the past three months.

Design outcomes

Primary

MeasureTime frame
Numerical rating scale (NRS) score at motion at 24 hours after surgery;

Secondary

MeasureTime frame
Pain score;Ramsay score;St. Mary's Hospital Sleep Score;Hospital Anxiety and Depression Score;QoR-15 Quality of Recovery Score;Satisfaction of patients and their families with postoperative analgesia treatment;

Countries

China

Contacts

Public ContactYang Jianjun

The First Affiliated Hospital of Zhengzhou University

zyy260340@163.com+86 13783537619

Outcome results

None listed

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