Efficacy of Esketamine Combined With Different General Anesthetics on Quality of Postoperative Recovery

Not Applicable

Active, not recruiting

• Conditions: Quality of Postoperative Recovery
• Interventions: Drug: normal saline; Drug: esketamine; Drug: ciprofol; Drug: propofol; Drug: etomidate-ciprofol (EC) mixture; Drug: etomidate-propofol (EP) mixture

• Registration Number: NCT06976996
• Lead Sponsor: Northern Jiangsu People's Hospital

Brief Summary

To explore the effect of subanesthetic-dose esketamine combined with different general anesthetic drugs on the quality of postoperative recovery in patients undergoing painless gastrointestinal endoscopy.

Detailed Description

In this study, we planned to conduct a single-center, prospective, randomized, controlled, double-blind clinical trial to explore the effect of subanesthetic dose esketamine combined with different general anesthesia drugs on the postoperative recovery quality of patients undergoing painless gastrointestinal endoscopy combined with several commonly used intravenous general anesthesia drugs, aiming at gastroscopy combined with colonoscopy, a representative type of diagnosis and treatment of painless and comfortable anesthesia, and to provide more evidence-based medical evidence for clinical work.

Study Timeline

• Study Start: 2025-03-16
• Status Verified: 2025-05
• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-10
• Last Update Submitted: 2025-05-10
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• (1) Aged between 18 and 75 years old (inclusive); (2) ASA (American Society of Anesthesiologists) physical status classification of Class I to III; (3) Body Mass Index (BMI) ranging from 18 to 30 kg/m²; (4) Individuals scheduled to undergo combined gastroscopy and colonoscopy under painless anesthesia; (5) Those with a patent airway and no history of difficult intubation or difficult airway management; (6) Individuals with intact cognitive function, who have provided informed consent, voluntarily participate in this study, and are capable of cooperating to complete data collection.

Exclusion Criteria

• （1）A history of unregulated diabetes mellitus, hypertension, or hypotension; （2）Concomitant hyperthyroidism or hypothyroidism; （3）Concomitant psychiatric or neurological disorders; （4）Severe hepatic or renal insufficiency; （5）Concomitant glaucoma, severe hearing or visual impairment that hinders cooperation; （6）Individuals with significant organ dysfunction; （7）Those with allergies to or contraindications for the study drug; （8）Patients with aneurysmal vascular diseases involving the thoracic or abdominal aorta, intracranial arteries, or peripheral arterial vessels; （9）Individuals who are unable to cooperate in completing the Quality of Recovery-15 (QoR-15) questionnaire.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group C	normal saline	normal saline (0.15 ml/kg) + ciprofol (0.5 mg/kg)
group C	ciprofol	normal saline (0.15 ml/kg) + ciprofol (0.5 mg/kg)
group E	esketamine	esketamine (0.15 mg/kg) + ciprofol (0.5 mg/kg)
group E	ciprofol	esketamine (0.15 mg/kg) + ciprofol (0.5 mg/kg)
group P	esketamine	esketamine (0.15 mg/kg) + propofol (2 mg/kg)
group P	propofol	esketamine (0.15 mg/kg) + propofol (2 mg/kg)
group EC	esketamine	esketamine (0.15 mg/kg) + etomidate-ciprofol (EC) mixture (0.2 ml/kg)
group EC	etomidate-ciprofol (EC) mixture	esketamine (0.15 mg/kg) + etomidate-ciprofol (EC) mixture (0.2 ml/kg)
group EP	esketamine	esketamine (0.15 mg/kg) + etomidate-propofol (EC) mixture (0.2 ml/kg)
group EP	etomidate-propofol (EP) mixture	esketamine (0.15 mg/kg) + etomidate-propofol (EC) mixture (0.2 ml/kg)

Primary Outcome Measures

Name	Time	Method
Quality of Recovery-15	Postoperative day 1 and 3	The QoR-15 (Quality of Recovery-15) evaluates the quality of recovery across five dimensions: physical comfort (50 points), emotional state (40 points), physical independence (20 points), psychological support (20 points), and pain (20 points). The total score of the QoR-15 ranges from 0 (indicating the poorest quality of recovery) to 150 (representing the best quality of recovery).

Secondary Outcome Measures

Name	Time	Method
Perioperative vital signs	Perioperative	The following parameters: Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP), Heart Rate (HR), and Peripheral Oxygen Saturation (SpO₂) were measured and recorded at the following time points: before anesthesia induction (T0), immediately after anesthesia induction (T1), at the moment when the gastroscope entered the larynx (T2), when the gastroscope was withdrawn from the pharyngeal cavity (T3), when the colonoscope entered the anus (T4), and at the completion of colonoscopy (T5).
Anesthesia Recovery Time	during surgery and arrived at PACU (up to 30 minutes after surgery)	The time interval between the last administration of general anesthetic agent(s) and the moment when the patient achieves a Modified Aldrete Score of ≥9.
Procedure Duration	during surgery and arrived at PACU (up to 30 minutes after surgery)	From the beginning of gastroscopy to the end of colonoscopy withdrawal
PACU residence time	during surgery and arrived at PACU (up to 30 minutes after surgery)	The time from entering the PACU to leaving the PACU after the end of gastroscopy combined with colonoscopy;
Anesthetic drug use	during surgery and arrived at PACU (up to 30 minutes after surgery)	Total amount of sedative medication used, number of cases of norepinephrine, and number of cases of remifentanil.
The way the patient leaves the endoscopy center	Postoperative	The way in which the patient is discharged from the PACU after the anesthesia resuscitation is up to standard;
The length of the patient's stay in the hospital after leaving the endoscopy center in the PACU	Postoperative	The length of the patient's stay in the hospital from the time the patient leaves the PACU until he leaves the hospital.
The way the patient leaves the hospital	Postoperative	The patient's method of leaving the hospital, such as walking on their own, driving any means of transportation, etc.
Satisfaction score	Postoperative	Patient, anesthesiologist, and digestive endoscopist satisfaction with the whole gastroscopy combined with colonoscopy. Using the NRS, eleven numbers from 0-10 represent satisfaction, with 0 being dissatisfied and 10 being the most satisfied.

Trial Locations

Locations (1)

Northern Jiangsu People's Hospital; 🇨🇳 Yangzhou, Jiangsu, China