Quality of Postoperative RecoveryNCT06976996
Efficacy of Esketamine Combined With Different General Anesthetics on Quality of Postoperative Recovery
A study testing normal saline, esketamine and propofol in people with Quality of Postoperative Recovery, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Quality of Postoperative Recovery
- What is being tested?
- normal saline, esketamine and propofol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- （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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Subanesthetic Dose of Esketamine Combined With Different General Anesthetics on Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy
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.
Read the 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.
- Conditions
- Quality of Postoperative Recovery
- Being tested
- normal saline, esketamine, propofol, etomidate-ciprofol (EC) mixture, ciprofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineDrug
normal saline (0.15 ml/kg)
esketamineDrug
Also called S-ketamine
esketamine (0.15 mg/kg)
propofolDrug
propofol (2 mg/kg)
etomidate-ciprofol (EC) mixtureDrug
etomidate-ciprofol (EC) mixture (0.2 ml/kg)
ciprofolDrug
ciprofol (0.5 mg/kg)
etomidate-propofol (EP) mixtureDrug
etomidate-propofol (EP) mixture (0.2 ml/kg)
| Study group | Role | What they receive |
|---|---|---|
| group C | Placebo comparator | normal saline (0.15 ml/kg) + ciprofol (0.5 mg/kg) Receives: Drug: normal saline; Drug: ciprofol |
| group E | Experimental | esketamine (0.15 mg/kg) + ciprofol (0.5 mg/kg) Receives: Drug: esketamine; Drug: ciprofol |
| group P | Experimental | esketamine (0.15 mg/kg) + propofol (2 mg/kg) Receives: Drug: esketamine; Drug: propofol |
| group EC | Experimental | esketamine (0.15 mg/kg) + etomidate-ciprofol (EC) mixture (0.2 ml/kg) Receives: Drug: esketamine; Drug: etomidate-ciprofol (EC) mixture |
| group EP | Experimental | esketamine (0.15 mg/kg) + etomidate-propofol (EC) mixture (0.2 ml/kg) Receives: Drug: esketamine; Drug: etomidate-propofol (EP) mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-15
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).
Measured: Postoperative day 1 and 3
Secondary outcomes (9)
Perioperative vital signs
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).
Measured: Perioperative
Anesthesia Recovery Time
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.
Measured: during surgery and arrived at PACU (up to 30 minutes after surgery)
Procedure Duration
From the beginning of gastroscopy to the end of colonoscopy withdrawal
Measured: during surgery and arrived at PACU (up to 30 minutes after surgery)
PACU residence time
The time from entering the PACU to leaving the PACU after the end of gastroscopy combined with colonoscopy;
Measured: during surgery and arrived at PACU (up to 30 minutes after surgery)
Anesthetic drug use
Total amount of sedative medication used, number of cases of norepinephrine, and number of cases of remifentanil.
Measured: during surgery and arrived at PACU (up to 30 minutes after surgery)
The way the patient leaves the endoscopy center
The way in which the patient is discharged from the PACU after the anesthesia resuscitation is up to standard;
Measured: Postoperative
The length of the patient's stay in the hospital after leaving the endoscopy center in the PACU
The length of the patient's stay in the hospital from the time the patient leaves the PACU until he leaves the hospital.
Measured: Postoperative
The way the patient leaves the hospital
The patient's method of leaving the hospital, such as walking on their own, driving any means of transportation, etc.
Measured: Postoperative
Satisfaction score
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.
Measured: Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start16 Mar 2025
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Postoperative RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Gao, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976996
- Sponsor's protocol ID
- 2025ky074
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Subanesthetic Dose of Esketamine Combined With Different General Anesthetics on Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT06976996
- Acronym / sponsor ID
- 2025ky074
- Conditions
- Quality of Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 16 Mar 2025 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| group C | Placebo comparator | Drug: normal saline, Drug: ciprofolnormal saline (0.15 ml/kg) + ciprofol (0.5 mg/kg) |
| group E | Experimental | Drug: esketamine, Drug: ciprofolesketamine (0.15 mg/kg) + ciprofol (0.5 mg/kg) |
| group P | Experimental | Drug: esketamine, Drug: propofolesketamine (0.15 mg/kg) + propofol (2 mg/kg) |
| group EC | Experimental | Drug: esketamine, Drug: etomidate-ciprofol (EC) mixtureesketamine (0.15 mg/kg) + etomidate-ciprofol (EC) mixture (0.2 ml/kg) |
| group EP | Experimental | Drug: esketamine, Drug: etomidate-propofol (EP) mixtureesketamine (0.15 mg/kg) + etomidate-propofol (EC) mixture (0.2 ml/kg) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- （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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal salinenormal saline (0.15 ml/kg) | Drug | group C |
| esketamineAlso: S-ketamineesketamine (0.15 mg/kg) | Drug | group E, group EC, group EP, group P |
| propofolpropofol (2 mg/kg) | Drug | group P |
| etomidate-ciprofol (EC) mixtureetomidate-ciprofol (EC) mixture (0.2 ml/kg) | Drug | group EC |
| ciprofolciprofol (0.5 mg/kg) | Drug | group C, group E |
| etomidate-propofol (EP) mixtureetomidate-propofol (EP) mixture (0.2 ml/kg) | Drug | group EP |
Primary outcome
Quality of Recovery-15
Time frame: 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).
9 secondary outcomes
Perioperative vital signs
Time frame: Perioperative
Anesthesia Recovery Time
Time frame: during surgery and arrived at PACU (up to 30 minutes after surgery)
Procedure Duration
Time frame: during surgery and arrived at PACU (up to 30 minutes after surgery)
PACU residence time
Time frame: during surgery and arrived at PACU (up to 30 minutes after surgery)
Anesthetic drug use
Time frame: during surgery and arrived at PACU (up to 30 minutes after surgery)
The way the patient leaves the endoscopy center
Time frame: Postoperative
The length of the patient's stay in the hospital after leaving the endoscopy center in the PACU
Time frame: Postoperative
The way the patient leaves the hospital
Time frame: Postoperative
Satisfaction score
Time frame: Postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal saline, esketamine and propofol in people with Quality of Postoperative Recovery, run by Northern Jiangsu People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 (time frame: Postoperative day 1 and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.