The Impact of Low-Dose Esketamine Combined With Ciprofol on the Quality of Early Postoperative Recovery Among Elderly Patients Undergoing Painless Gastroscopy

Lead sponsor

Subei People's Hospital of Jiangsu Province is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Study arms

• Active comparator
  Ciprofol group (C group)

  Ciprofol group will be started with ciprofol 0.2-0.4 mg/kg.

  Drug: Ciprofol

• Experimental
  The group of remifentanil 0.5ug/kg combined with ciprofol(R group)

  R group will be started with remifentanil 0.5ug/kg and ciprofol 0.2-0.4 mg/kg.

  Drug: Remifentanil and ciprofol

• Experimental
  The group of esketamine 0.3mg/kg combined with ciprofol(E1 group)

  E1 group will be started with esketamine 0.3mg/kg and ciprofol 0.2-0.4 mg/kg.

  Drug: esketamine 0.3mg/kg and ciprofol

• Experimental
  The group of esketamine 0.5mg/kg combined with ciprofol(E2 group)

  E2 group will be started with esketamine 0.5mg/kg and ciprofol 0.2-0.4 mg/kg.

  Drug: esketamine 0.5mg/kg and ciprofol

Interventions

• DrugRemifentanil and ciprofol

  R group will be started with remifentanil 0.5ug/kg and ciprofol 0.4 mg/kg.

• Drugesketamine 0.3mg/kg and ciprofol

  Anesthesia induction was initiated by esketamine 0.3mg/kg, followed by ciprofol 0.2-0.4mg/kg.

• Drugesketamine 0.5mg/kg and ciprofol

  Anesthesia induction was initiated by esketamine 0.5mg/kg, followed by ciprofol 0.2-0.4mg/kg.

• DrugCiprofol

  Ciprofol group will be started with ciprofol 0.2-0.4 mg/kg.

Primary outcomes

1. postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score

   Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1(minimum value : 0, maximum value : 150, the higher the score, the better the result)

   Time frame: Baseline (30 min before surgery), postoperative day 1

Secondary outcomes

1. postoperative day 3(POD3) Quality of Recovery(QoR)-15 questionnaire score

   Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 3(minimum value : 0, maximum value : 150, the higher the score, the better the result)

   Time frame: Postoperative day 3 and 7

2. Cognitive function assessment

   A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory). MMSE has a maximum total score of 30, with higher scores manifesting a better cognitive performance.

   Time frame: Baseline (30 min before surgery), postoperative day 1,3 and 7

3. Hospital anxiety and depression scale ( HADS ) score.

   Postoperative anxiety and depression scores will be measured by the Hospital Anxiety and Depression Scale, on the morning(8-10 am) of postoperative days (PODs) 1,3 and 7 , a score of 8 points or higher will be diagnosed as depression or anxiety.

   Time frame: Baseline (30 min before surgery), postoperative day 1,3 and 7

4. Dosage of ciprofol

   Consumption of ciprofol during endoscopic examination

   Time frame: During endoscopic examination

5. Heart rate (HR)

   Throughout the procedure, the heart rate (HR) was continuously monitored.

   Time frame: Baseline，during surgery and arrived at PACU (up to 30 minutes after surgery)

6. Pulse oxygen saturation (SpO2)

   Throughout the procedure, the pulse oxygen saturation (SpO2) were continuously monitored.

   Time frame: Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery)

7. Mean blood pressure (MBP)

   Throughout the procedure, the mean blood pressure (MBP) was measured at 1-minute intervals.

   Time frame: Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery)

8. Patient satisfaction levels

   The patients express their satisfaction with procedures on a visual analogue score, ranging from 0 to 10, where 0 is the minimum and 10 is the maximum satisfaction level.

   Time frame: 30 minutes at recovery room.

Other outcomes

1. The incidence of all drug-related adverse events

   All drug-related adverse events including bradycardia, hypotension, tachycardia, hypertension, arrhythmia, nystagmus, hypersalivation, euphoria, emergence agitation, hallucinations, dreaminess and nightmares during surgery or before discharge.etc.Patients will be followed up for 3 days consecutively(at 8-10am).

   Time frame: Within 72hours after surgery

Individual participant data

Plan to share: No