Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients

NCT06108830 | Recruiting DMC

• 1 other identifier: GWang024
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the effects of esketamine combined with remimazolam on postoperative sleep disturbance and anxiety in surgical patients undergoing gastroenteroscopies

Conditions

Sleep Disturbance

Keywords

Esketamine; remimazolam; anxiety; gastroenteroscopy

Outcome Measures

Primary Outcomes (1)

• Sleep disturbance and anxiety after surgery

  Patients completed the sleep quality (AIS, Athens Insomnia Scale) and anxiety (Hospital Anxiety and Depression Scale) rating scales on the day before surgery. HADS consists of 14 items to calculate the patient's comprehensive score, including 7 anxiety related scores and 7 depression related scores. Each question in the questionnaire was scored on a scale of 0-3, so patients scored 0-21 on both anxiety and depression. Scores of 8 points or higher are diagnosed as depression or anxiety.And we asked the patients to fill out these questionnaires on the day 1 and 3 after surgery again to evaluate the changes in sleep quality and anxiety. (The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia). . We recorded AIS scores, HDS-A scores and HDS-D scores as separate statistical indicators.

  1 day before surgery, 1 and 3 days after surgery

Secondary Outcomes (12)

• Pain Score (NRS)

  1 and 3 days after surgery

• Incidence of injection pain

  Intraoperative

• Dosage of drug

  Intraoperative

• Mean intraoperative blood pressure

  Intraoperative

• Oxygen saturation

  Intraoperative

Study Arms (4)

Group of patients undergoing gastroenteroscopies with normal saline

PLACEBO COMPARATOR

Patients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began

Drug: normal saline

Group of patients undergoing gastroenteroscopies with esketamine

ACTIVE COMPARATOR

Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began

Drug: Esketamine

Group of patients undergoing gastroenteroscopies with remimazolam

ACTIVE COMPARATOR

Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began

Drug: Remimazolam

Group of patients undergoing gastroenteroscopies with remimazolam and esketamine

ACTIVE COMPARATOR

Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg， esketamine 0.2mg/kg and remimazolam 0.15mg/kg before the procedure began

Drug: Esketamine and remimazolam

Interventions

Esketamine DRUG

Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began

Also known as: Group of patients undergoing gastroenteroscopies with esketamine

Group of patients undergoing gastroenteroscopies with esketamine

Remimazolam DRUG

Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began

Also known as: Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began

Group of patients undergoing gastroenteroscopies with remimazolam

Esketamine and remimazolam DRUG

Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began

Also known as: Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg， esketamine 0.2mg/kg and remimazolam 0.15mg/kg before the procedure began

Group of patients undergoing gastroenteroscopies with remimazolam and esketamine

normal saline DRUG

Patients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began

Also known as: Group of patients undergoing gastroenteroscopies with normal saline

Group of patients undergoing gastroenteroscopies with normal saline

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-65 years old;
• ASA classification is grade I-III;
• Elective surgery is proposed
• BMI of 19-30 kg/m2;
• Patients who agreed to enroll in this study voluntarily

You may not qualify if:

• Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;
• Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
• History of neurological diseases; History of chronic pain; Drug and alcohol addiction; A long history of opioid use; Opiates were given 48 hours before surgery;
• ASA rating of IV or V;
• Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
• History of gastrointestinal disease (peptic ulcer, Crohn's disease, ulcerative colitis);
• Respiratory insufficiency, respiratory failure;
• Patients who refused to use intravenous PCA for analgesia;
• Pregnant or lactating women;
• BMI\<18 kg/m2 or BMI\>30kg/m2;
• Poor compliance, unable to complete the experiment according to the study plan;
• Participants who have participated in clinical trials of other drugs within the last 4 weeks;

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, 300052, China

RECRUITING

MeSH Terms

Conditions

Parasomnias; Anxiety Disorders

Interventions

Esketamine; remimazolam; Saline Solution

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Guolin Wang

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

Central Study Contacts

Guolin Wang, MD

CONTACT

+8615822855556; wangguolinghad@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: Professor

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: October 31, 2023
• Study Start: December 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 10, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)