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

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108830
• Other study ID #: GWang024
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: June 10, 2024

Study information

• Verified date: April 2024
• Source: Tianjin Medical University General Hospital
• Contact: Guolin Wang, MD
• Phone: +8615822855556
• Email: wangguolinghad[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 10, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Drug:
• Esketamine
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began
• Remimazolam
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began
• Esketamine and remimazolam
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began
• normal saline
Patients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Incidence of injection pain	The frequency of injection pain induced by propofol was recorded	Intraoperative
Secondary	Dosage of drug	The dosage of propofol, esketamine and remimazolam were recorded	Intraoperative
Secondary	Mean intraoperative blood pressure	The mean intraoperative blood pressure was recorded	Intraoperative
Secondary	Oxygen saturation	The mean intraoperative oxygen saturation was recorded	Intraoperative
Secondary	Somatokinetic reaction	The number of intraoperative body movements was recorded	Intraoperative
Secondary	Operation time	The duration of the patient's operation was recorded(up to 24 h)	Intraoperative
Secondary	Duration of anesthesia	The patient's duration of anesthesia was recorded(up to 24 h)	After surgery
Secondary	Time of awakening	The duration from the end of anesthesia to recovery was recorded(up to 24 h)	After surgery
Secondary	Time to walking down	Record the time from waking up to walking down(up to 24 h)	After surgery
Secondary	Adverse event	All kinds of adverse events occurred in patients were recorded	Within 3 days after surgery
Secondary	Exhaust time	Records from end of anesthesia to patients with postoperative exhaust time for the first time	Within 3 days after surgery