RecruitingNot ApplicableNCT06108830

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


Sponsor

Tianjin Medical University General Hospital

Enrollment

400 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 20 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria13

  • 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.

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Interventions

DRUGEsketamine

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

DRUGRemimazolam

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

DRUGEsketamine and remimazolam

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

DRUGnormal saline

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


Locations(1)

Tianjin Medical University General Hospital

Tianjin, China

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NCT06108830


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