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

Sponsor

Tianjin Medical University General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06108830

Collaborator

(none)

400

Enrollment

Arms

2.3

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sleep Disturbance	Drug: Esketamine Drug: Remimazolam Drug: Esketamine and remimazolam Drug: normal saline	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Feb 10, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Sleep disturbance and anxiety after surgery [1 day before surgery, 1 and 3 days 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.

Secondary Outcome Measures

Pain Score (NRS) [1 and 3 days after surgery]
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.
Incidence of injection pain [Intraoperative]
The frequency of injection pain induced by propofol was recorded
Dosage of drug [Intraoperative]
The dosage of propofol, esketamine and remimazolam were recorded
Mean intraoperative blood pressure [Intraoperative]
The mean intraoperative blood pressure was recorded
Oxygen saturation [Intraoperative]
The mean intraoperative oxygen saturation was recorded
Somatokinetic reaction [Intraoperative]
The number of intraoperative body movements was recorded
Operation time [Intraoperative]
The duration of the patient's operation was recorded(up to 24 h)
Duration of anesthesia [After surgery]
The patient's duration of anesthesia was recorded(up to 24 h)
Time of awakening [After surgery]
The duration from the end of anesthesia to recovery was recorded(up to 24 h)
Time to walking down [After surgery]
Record the time from waking up to walking down(up to 24 h)
Adverse event [Within 3 days after surgery]
All kinds of adverse events occurred in patients were recorded
Exhaust time [Within 3 days after surgery]
Records from end of anesthesia to patients with postoperative exhaust time for the first time

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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;
Any circumstances deemed unsuitable for inclusion by the researcher for any reason.