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

Effect of Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Gastroenteroscopies

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

Study Overview

• Status: Recruiting
• Conditions: Sleep Disturbance
• Intervention / Treatment: Drug: normal saline; Drug: Esketamine; Drug: Remimazolam; Drug: Esketamine and remimazolam

Detailed Description

Postoperative sleep disturbance (PSD) occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities, and have a high incidence in patients undergoing surgery. Postoperative sleep disorders can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative acute pain, and delay postoperative recovery.

Benzodiazepines have a certain sedative hypnotic anti-anxiety effect, and remimazolam as a new benzodiazepine, its sedative hypnotic anti-anxiety effect is worthy of further exploration.Esketamine is an NMDA receptor antagonist with analgesic and sedative effects, and is widely used in clinical treatment of refractory depression. For patients undergoing surgery, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on postoperative sleep disturbance and anxiety is worth exploring.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guolin Wang, MD; Phone Number: +8615822855556; Email: wangguolinghad@hotmail.com

Study Locations

• China
  • Tianjin, China, 300052
    • Recruiting
    • Tianjin Medical University General Hospital
    • Contact: Guolin Wang; Phone Number: +8618604755166

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;
2. Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
3. 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;
4. ASA rating of IV or V;
5. Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
6. History of gastrointestinal disease (peptic ulcer, Crohn's disease, ulcerative colitis);
7. Respiratory insufficiency, respiratory failure;
8. Patients who refused to use intravenous PCA for analgesia;
9. Pregnant or lactating women;
10. BMI<18 kg/m2 or BMI>30kg/m2;
11. Poor compliance, unable to complete the experiment according to the study plan;
12. Participants who have participated in clinical trials of other drugs within the last 4 weeks;
13. Any circumstances deemed unsuitable for inclusion by the researcher for any reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group of patients undergoing gastroenteroscopies with normal saline; Patients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began	Drug: normal saline; Patients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began; Other Names: Group of patients undergoing gastroenteroscopies with normal saline
Active Comparator: Group of patients undergoing gastroenteroscopies with esketamine; Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began	Drug: Esketamine; Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began; Other Names: Group of patients undergoing gastroenteroscopies with esketamine
Active Comparator: Group of patients undergoing gastroenteroscopies with remimazolam; Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began	Drug: Remimazolam; Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began; Other Names: Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began
Active Comparator: Group of patients undergoing gastroenteroscopies with remimazolam and esketamine; 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; Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began; Other Names: Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg， esketamine 0.2mg/kg and remimazolam 0.15mg/kg before the procedure began

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score (NRS)	The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.	1 and 3 days after surgery
Incidence of injection pain	The frequency of injection pain induced by propofol was recorded	Intraoperative
Dosage of drug	The dosage of propofol, esketamine and remimazolam were recorded	Intraoperative
Mean intraoperative blood pressure	The mean intraoperative blood pressure was recorded	Intraoperative
Oxygen saturation	The mean intraoperative oxygen saturation was recorded	Intraoperative
Somatokinetic reaction	The number of intraoperative body movements was recorded	Intraoperative
Operation time	The duration of the patient's operation was recorded(up to 24 h)	Intraoperative
Duration of anesthesia	The patient's duration of anesthesia was recorded(up to 24 h)	After surgery
Time of awakening	The duration from the end of anesthesia to recovery was recorded(up to 24 h)	After surgery
Time to walking down	Record the time from waking up to walking down(up to 24 h)	After surgery
Adverse event	All kinds of adverse events occurred in patients were recorded	Within 3 days after surgery
Exhaust time	Records from end of anesthesia to patients with postoperative exhaust time for the first time	Within 3 days after surgery

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital
• Investigators: Study Director: Guolin Wang, Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 10, 2024

Study Registration Dates

• First Submitted: August 27, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: anxiety; Esketamine; remimazolam; gastroenteroscopy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Psychotropic Drugs; Antidepressive Agents; Hypnotics and Sedatives; Propofol; Esketamine
• Other Study ID Numbers: GWang024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No