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Recruiting NCT06108830

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

No phase Interventional Sleep Disturbance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Esketamine, Remimazolam, Esketamine and remimazolam, normal saline.
Who it may be relevant to
Registry conditions: Sleep Disturbance. Basic parameters: 20 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

  • Drug Esketamine
    Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/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
  • Drug Esketamine and remimazolam
    Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg 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

Primary outcome measures

  • Sleep disturbance and anxiety after surgery [Time frame: 1 day before surgery, 1 and 3 days after surgery]
Secondary outcome measures (12)
  • Pain Score (NRS) [Time frame: 1 and 3 days after surgery]
  • Incidence of injection pain [Time frame: Intraoperative]
  • Dosage of drug [Time frame: Intraoperative]
  • Mean intraoperative blood pressure [Time frame: Intraoperative]
  • Oxygen saturation [Time frame: Intraoperative]
  • Somatokinetic reaction [Time frame: Intraoperative]
  • Operation time [Time frame: Intraoperative]
  • Duration of anesthesia [Time frame: After surgery]
  • Time of awakening [Time frame: After surgery]
  • Time to walking down [Time frame: After surgery]
  • Adverse event [Time frame: Within 3 days after surgery]
  • Exhaust time [Time frame: Within 3 days after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Tianjin Medical University General Hospital — Tianjin

Identifiers

NCT: NCT06108830 · GWang024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗