The Effect of Subclinical Dose of Ketamine on Early Postoperative Pain Sensitivity in Patients Undergoing Salpingectomy

NCT06559280 | Completed Early Phase 1

• 1 other identifier: K2023-11-022
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The experiment aims to explore the clinical effect of subclinical doses of ketamine on early postoperative pain sensitivity in ectopic pregnancy population.

Conditions

Ectopic Pregnancy

Outcome Measures

Primary Outcomes (1)

• Postoperative pain sensitivity

  The pain sensitivity scale is used to measure the pain sensitivity of patients. Patients imagine certain scenarios in their daily lives and score their pain to evaluate their individual pain sensitivity. This scale contains 17 items, requiring testers to fill in a number on the numerical rating scale from 0 (no pain) to 10 (most pain) to indicate the degree of pain in this situation. There are three items interspersed among them that describe situations where there is no pain under normal circumstances, as a reference for testers to feel no pain. In addition, the 14 pain items cover various types of pain and pain intensity levels, and completing the PSQ generally takes 5-10 minutes. The total score of PSQ is based on the average score of 14 pain items, ranging from 0 to 10. The results are divided into two categories: PSQ moderate and PSQ minor, which reflect the expected pain levels of different intensity stimuli. The higher the score, the more sensitive it is to pain stimuli.

  Preoperative, one day after surgery, the second day after surgery, and one week after surgery

Study Arms (2)

experimental group

EXPERIMENTAL

Use ketamine for postoperative analgesia and intraoperative induction

Drug: esketamine

control group

NO INTERVENTION

Not using ketamine for postoperative analgesia and intraoperative induction

Interventions

esketamine DRUG

During the operation, 0.25mg/kg esketamine was induced, and 1mg/kg esketamine was added to the postoperative analgesia pump

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years old
• BMI 18-30 kg/m2;
• American Society of Anesthesiologists (ASA) classification I and II
• The patient was diagnosed with ectopic pregnancy through ultrasound examination, and it was confirmed that there was no embryo or gestational sac in the uterus; The patient has indications for laparoscopic ectopic pregnancy surgery;
• All patients are scheduled to undergo laparoscopic salpingectomy for treatment Normal mental state;
• No cognitive impairment;
• Normal communication skills, no speech barriers

You may not qualify if:

• Individuals with severe organ dysfunction such as heart, lungs, liver, and kidneys;
• Individuals with serious mental illnesses;
• Long term use of sedatives and analgesics or long-term alcoholism and smoking;
• History of allergy to ketamine and related drugs
• There is a serious risk of hypertension or elevated intracranial pressure, as well as contraindications for the use of ketamine in cases of hyperthyroidism Refuse to join the trial;
• Patients with a history of other chronic pain diseases.

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

Study Sites (1)

Fuzhou University affiliated Provincial Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 19, 2024
• Study Start: August 24, 2024
• Primary Completion: August 20, 2025
• Study Completion: August 20, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)