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

ConditionSleep Disturbance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorTianjin Medical University General Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 20-65 years old;

ASA classification is grade I-III;

Elective surgery is proposed

BMI of 19-30 kg/m2;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Esketamine

    Drug

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

  • Remimazolam

    Drug

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

  • Esketamine and remimazolam

    Drug

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

  • normal saline

    Drug

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

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Group of patients undergoing gastroenteroscopies with normal salinePlacebo comparator 1 intervention
Group B: Group of patients undergoing gastroenteroscopies with esketamineActive comparator 1 intervention
Group C: Group of patients undergoing gastroenteroscopies with remimazolamActive comparator 1 intervention
Group D: Group of patients undergoing gastroenteroscopies with remimazolam and esketamineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 day before surgery, 1 and 3 days after surgery

Secondary outcomes

1

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.

Time frame
1 and 3 days after surgery
2

Incidence of injection pain

The frequency of injection pain induced by propofol was recorded

Time frame
Intraoperative
3

Dosage of drug

The dosage of propofol, esketamine and remimazolam were recorded

Time frame
Intraoperative
4

Mean intraoperative blood pressure

The mean intraoperative blood pressure was recorded

Time frame
Intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University General Hospital

Lead sponsor

Source ClinicalTrials.gov
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