Quality of Postoperative RecoveryNCT06617039
The Impact of Low-Dose Esketamine Combined With Ciprofol on the Quality of Early Postoperative Recovery Among Elderly Patients Undergoing Painless Gastroscopy
A study testing Remifentanil and ciprofol, esketamine 0.3mg/kg and ciprofol and esketamine 0.5mg/kg and ciprofol in people with Quality of Postoperative Recovery, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
To explore the impact of esketamine combined with ciprofol on the quality of early postoperative recovery in elderly patients undergoing painless gastroscopy, as well as the effectiveness and safety of this regimen. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Postoperative Recovery
- What is being tested?
- Remifentanil and ciprofol, esketamine 0.3mg/kg and ciprofol and esketamine 0.5mg/kg and ciprofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 15 Jul 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Scheduled painless gastroscopy examination and treatment
- 2. Age 60-75 years old
- 3. ASA grade Ⅰ-Ⅱ
- 4. The respiratory tract is unobstructed and there is no difficult airway
- 5. No history of allergy to etomidate and cyclopropofol
- 6. Participants with normal heart, liver, lung, and kidney functions
- 7. Able to complete the QoR-15, MMSE, and HADS scale assessments
- 8. lnformed consent, voluntary participation in the trial, and signed by the patient informed consent
Who cannot join
- 1. Participants with concurrent dysfunction of major organs.
- 2. Participants with a history of mental illness and abuse of sedative drugs
- 3. Participants with allergies or contraindications to the study drugs
- 4. Participants with severe visual, auditory, or speech communication impairments
- 5. Participants with acute gastrointestinal inflammation or obstruction
- 6. History of uncontrolled diabetes, hypertension, and hypotension
Show all 9Show fewer
- 7. Participants with malignant tumors, severe hyperkalemia, bronchial asthma, or excessive obesity (BMI \> 30kg/m2)
- 8. Participants with aneurysmal vascular diseases of the thoracic and abdominal aorta, intracranial and peripheral arterial vessels.
- 9. Unable to cooperate with the QoR-15, MMSE, and HADS scale assessments
Trial locations and contacts
1 site in 1 country.
China1 site
Subei People's Hospital of Jiangsu Province
Yangzhou, Jiangsu, 225001
About this study
To explore the impact of esketamine combined with ciprofol on the quality of early postoperative recovery in elderly patients undergoing painless gastroscopy, as well as the effectiveness and safety of this regimen.
- Conditions
- Quality of Postoperative Recovery
- Being tested
- Remifentanil and ciprofol, esketamine 0.3mg/kg and ciprofol, esketamine 0.5mg/kg and ciprofol, Ciprofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil and ciprofolDrug
R group will be started with remifentanil 0.5ug/kg and ciprofol 0.4 mg/kg.
esketamine 0.3mg/kg and ciprofolDrug
Anesthesia induction was initiated by esketamine 0.3mg/kg, followed by ciprofol 0.2-0.4mg/kg.
esketamine 0.5mg/kg and ciprofolDrug
Anesthesia induction was initiated by esketamine 0.5mg/kg, followed by ciprofol 0.2-0.4mg/kg.
CiprofolDrug
Ciprofol group will be started with ciprofol 0.2-0.4 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol group (C group) | Active comparator | Ciprofol group will be started with ciprofol 0.2-0.4 mg/kg. Receives: Drug: Ciprofol |
| The group of remifentanil 0.5ug/kg combined with ciprofol(R group) | Experimental | R group will be started with remifentanil 0.5ug/kg and ciprofol 0.2-0.4 mg/kg. Receives: Drug: Remifentanil and ciprofol |
| The group of esketamine 0.3mg/kg combined with ciprofol(E1 group) | Experimental | E1 group will be started with esketamine 0.3mg/kg and ciprofol 0.2-0.4 mg/kg. Receives: Drug: esketamine 0.3mg/kg and ciprofol |
| The group of esketamine 0.5mg/kg combined with ciprofol(E2 group) | Experimental | E2 group will be started with esketamine 0.5mg/kg and ciprofol 0.2-0.4 mg/kg. Receives: Drug: esketamine 0.5mg/kg and ciprofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline (30 min before surgery), postoperative day 1
Secondary outcomes (8)
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)
Measured: Postoperative day 3 and 7
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.
Measured: Baseline (30 min before surgery), postoperative day 1,3 and 7
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.
Measured: Baseline (30 min before surgery), postoperative day 1,3 and 7
Dosage of ciprofol
Consumption of ciprofol during endoscopic examination
Measured: During endoscopic examination
Heart rate (HR)
Throughout the procedure, the heart rate (HR) was continuously monitored.
Measured: Baseline，during surgery and arrived at PACU (up to 30 minutes after surgery)
Pulse oxygen saturation (SpO2)
Throughout the procedure, the pulse oxygen saturation (SpO2) were continuously monitored.
Measured: Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery)
Mean blood pressure (MBP)
Throughout the procedure, the mean blood pressure (MBP) was measured at 1-minute intervals.
Measured: Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery)
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.
Measured: 30 minutes at recovery room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start10 Oct 2024
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 376 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
- NCT06617039
- Sponsor's protocol ID
- 2024ky251
- Status last verified
- May 2025
- First submitted
- 20 Sep 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Low-Dose Esketamine Combined With Ciprofol on the Quality of Early Postoperative Recovery Among Elderly Patients Undergoing Painless Gastroscopy
- ClinicalTrials.gov ID
- NCT06617039
- Acronym / sponsor ID
- 2024ky251
- Conditions
- Quality of Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 27 Sep 2024 (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 impact of esketamine combined with ciprofol on the quality of early postoperative recovery in elderly patients undergoing painless gastroscopy, as well as the effectiveness and safety of this regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ciprofol group (C group) | Active comparator | Drug: CiprofolCiprofol group will be started with ciprofol 0.2-0.4 mg/kg. |
| The group of remifentanil 0.5ug/kg combined with ciprofol(R group) | Experimental | Drug: Remifentanil and ciprofolR group will be started with remifentanil 0.5ug/kg and ciprofol 0.2-0.4 mg/kg. |
| The group of esketamine 0.3mg/kg combined with ciprofol(E1 group) | Experimental | Drug: esketamine 0.3mg/kg and ciprofolE1 group will be started with esketamine 0.3mg/kg and ciprofol 0.2-0.4 mg/kg. |
| The group of esketamine 0.5mg/kg combined with ciprofol(E2 group) | Experimental | Drug: esketamine 0.5mg/kg and ciprofolE2 group will be started with esketamine 0.5mg/kg and ciprofol 0.2-0.4 mg/kg. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Scheduled painless gastroscopy examination and treatment
- 2. Age 60-75 years old
- 3. ASA grade Ⅰ-Ⅱ
- 4. The respiratory tract is unobstructed and there is no difficult airway
- 5. No history of allergy to etomidate and cyclopropofol
Key exclusion criteria (9 listed)
- 1. Participants with concurrent dysfunction of major organs.
- 2. Participants with a history of mental illness and abuse of sedative drugs
- 3. Participants with allergies or contraindications to the study drugs
- 4. Participants with severe visual, auditory, or speech communication impairments
- 5. Participants with acute gastrointestinal inflammation or obstruction
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 |
|---|---|---|
| Remifentanil and ciprofolR group will be started with remifentanil 0.5ug/kg and ciprofol 0.4 mg/kg. | Drug | The group of remifentanil 0.5ug/kg combined with ciprofol(R group) |
| esketamine 0.3mg/kg and ciprofolAnesthesia induction was initiated by esketamine 0.3mg/kg, followed by ciprofol 0.2-0.4mg/kg. | Drug | The group of esketamine 0.3mg/kg combined with ciprofol(E1 group) |
| esketamine 0.5mg/kg and ciprofolAnesthesia induction was initiated by esketamine 0.5mg/kg, followed by ciprofol 0.2-0.4mg/kg. | Drug | The group of esketamine 0.5mg/kg combined with ciprofol(E2 group) |
| CiprofolCiprofol group will be started with ciprofol 0.2-0.4 mg/kg. | Drug | Ciprofol group (C group) |
Primary outcome
postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score
Time frame: Baseline (30 min before surgery), postoperative day 1
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)
8 secondary outcomes
postoperative day 3(POD3) Quality of Recovery(QoR)-15 questionnaire score
Time frame: Postoperative day 3 and 7
Cognitive function assessment
Time frame: Baseline (30 min before surgery), postoperative day 1,3 and 7
Hospital anxiety and depression scale ( HADS ) score.
Time frame: Baseline (30 min before surgery), postoperative day 1,3 and 7
Dosage of ciprofol
Time frame: During endoscopic examination
Heart rate (HR)
Time frame: Baseline，during surgery and arrived at PACU (up to 30 minutes after surgery)
Pulse oxygen saturation (SpO2)
Time frame: Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery)
Mean blood pressure (MBP)
Time frame: Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery)
Patient satisfaction levels
Time frame: 30 minutes at recovery room.
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 7 May 2025.
- Individual participant dataSharing planned: No
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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 Remifentanil and ciprofol, esketamine 0.3mg/kg and ciprofol and esketamine 0.5mg/kg and ciprofol 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 8 inclusion and 9 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 7 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. 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?
postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score (time frame: Baseline (30 min before surgery), postoperative day 1). 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 7 May 2025.