Opioid Use, UnspecifiedNCT05242081
Study on Opioid-free Anesthesia Protocol With S-ketamine and Propofol
A study testing S-ketamine and Sufentanil in people with Opioid Use, Unspecified and S-ketamine, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this study was to observe the effects of opioid-free anesthesia with S-ketamine on postoperative analgesia and perioperative hemodynamics in short surgical operations, and to explore the effects of S-ketamine on postoperative awakening time and extubation time, nausea and vomiting, hypoxemia, and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use, Unspecified, S-ketamine
- What is being tested?
- S-ketamine and Sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 980 participants
- Where
- 1 siteChina
- Study dates
- Jul 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 years to 65 years
- American society of anesthesiologists physical status classification I-II
- Patients scheduled for elective laparoscopic cholecystectomy
- Willing to sign informed consent
Who cannot join
- Allergic to narcotic drugs;
- Surgical history within the past 1 month;
- patients with neurological diseases or mental disorders;
- Unable to understand numerical rating Scale (NRS);
- patients with untreated or poorly controlled hypertension (arterial hypertension, resting systolic/diastolic blood pressure over 180/100mmHg);
- patients with untreated or undertreated hyperthyroidism;
- Patients with unstable angina pectoris or myocardial infarction in the past 6 months;
- When intraocular pressure is high (glaucoma) and penetrating ocular trauma, intraocular pressure cannot rise.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Chun Yang, +86 18260062666, chunyang@njmu.edu.cn
Chun Yang, Dr.
About this study
Official title: Efficacy and Safety of Opioid-free Anesthesia With Propofol Combined With S-ketamine in Laparoscopic Cholecystectomy: a Multicenter, Randomized, Controlled, Non-inferiority Clinical Study (SKOF - LC)
The purpose of this study was to observe the effects of opioid-free anesthesia with S-ketamine on postoperative analgesia and perioperative hemodynamics in short surgical operations, and to explore the effects of S-ketamine on postoperative awakening time and extubation time, nausea and vomiting, hypoxemia, and delirium.
- Conditions
- Opioid Use, Unspecified, S-ketamine
- Being tested
- S-ketamine, Sufentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-ketamineDrug
S-ketamine 0.5mg/kg for induction and 0.2mg/kg/h for maintenance
SufentanilDrug
Sufentanil 0.2-0.3μg/kg for induction and remifentanil 0.05-0.15μg/kg/min for maintenance
| Study group | Role | What they receive |
|---|---|---|
| S-ketamine | Experimental | Not described Receives: Drug: S-ketamine |
| Sufentanil | Active comparator | Not described Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The probability of numerical rating scale (NRS) score being less than or equal to 3 when leaving the Postanesthesia Care Unit (PACU)
The probability of numerical rating scale (NRS) score being less than or equal to 3 when leaving the Postanesthesia Care Unit (PACU)
Measured: 1 day of the surgery
Secondary outcomes (13)
The area under the curve (AUC) of mean arterial pressure (MAP) within 10 minutes after induction is lower than the baseline mean arterial pressure (MAP 3 minutes before induction).
The area under the curve (AUC) of mean arterial pressure (MAP) within 10 minutes after induction is lower than the baseline mean arterial pressure (MAP 3 minutes before induction).
Measured: From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days
herat rate and blood pressure during the surgery every 5 minutes
Measured: From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days
Total dosage of anesthesia drug
Measured: From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days
Total dosage of vasoactive agents
Measured: From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days
The duration of surgery
Measured: From the date of the beginning of surgery until the date of the end of surgery, assessed up to 2 days
Time until awake
Measured: From the end of anesthesia until awake, assessed up to 2 days
Time to removal of tracheal intubation
Measured: From the end of anesthesia until the time of removal of tracheal intubation, assessed up to 2 days
Incidence of postoperative nausea and vomiting
Measured: 48 hours after the surgery
Incidence of postoperative delirium
Measured: 48 hours after the surgery
Incidence of hypoxemia
Measured: 48 hours after the surgery
Postoperative first analgesia demand
The first time that the patient ask for analgesia
Measured: From the end of anesthesia until the date of first demand of analgesia drugs, assessed up to 1 week
numerical rating scale (NRS) pain score
Measured: 24 hours and 48 hours after the surgery
Postoperative hospital stay
Measured: From the date of the surgery until the date being discharged from hospital, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study startJul 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use, UnspecifiedStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242081
- Sponsor's protocol ID
- 2021-SR-480
- Status last verified
- Jul 2022
- First submitted
- 13 Jan 2022
- Last updated
- 20 Jul 2022
- 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 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Opioid-free Anesthesia With Propofol Combined With S-ketamine in Laparoscopic Cholecystectomy: a Multicenter, Randomized, Controlled, Non-inferiority Clinical Study (SKOF - LC)
- ClinicalTrials.gov ID
- NCT05242081
- Acronym / sponsor ID
- 2021-SR-480
- Conditions
- Opioid Use, Unspecified, S-ketamine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 980 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 16 Feb 2022 (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.
The purpose of this study was to observe the effects of opioid-free anesthesia with S-ketamine on postoperative analgesia and perioperative hemodynamics in short surgical operations, and to explore the effects of S-ketamine on postoperative awakening time and extubation time, nausea and vomiting, hypoxemia, and delirium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-ketamine | Experimental | Drug: S-ketamine |
| Sufentanil | Active comparator | Drug: Sufentanil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged from 18 years to 65 years
- American society of anesthesiologists physical status classification I-II
- Patients scheduled for elective laparoscopic cholecystectomy
- Willing to sign informed consent
Key exclusion criteria (8 listed)
- Allergic to narcotic drugs;
- Surgical history within the past 1 month;
- patients with neurological diseases or mental disorders;
- Unable to understand numerical rating Scale (NRS);
- patients with untreated or poorly controlled hypertension (arterial hypertension, resting systolic/diastolic blood pressure over 180/100mmHg);
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 |
|---|---|---|
| S-ketamineS-ketamine 0.5mg/kg for induction and 0.2mg/kg/h for maintenance | Drug | S-ketamine |
| SufentanilSufentanil 0.2-0.3μg/kg for induction and remifentanil 0.05-0.15μg/kg/min for maintenance | Drug | Sufentanil |
Primary outcome
The probability of numerical rating scale (NRS) score being less than or equal to 3 when leaving the Postanesthesia Care Unit (PACU)
Time frame: 1 day of the surgery
The probability of numerical rating scale (NRS) score being less than or equal to 3 when leaving the Postanesthesia Care Unit (PACU)
13 secondary outcomes
The area under the curve (AUC) of mean arterial pressure (MAP) within 10 minutes after induction is lower than the baseline mean arterial pressure (MAP 3 minutes before induction).
Time frame: From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days
herat rate and blood pressure during the surgery every 5 minutes
Time frame: From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days
Total dosage of anesthesia drug
Time frame: From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days
Total dosage of vasoactive agents
Time frame: From the date of the beginning of anesthesia until the date of the end of anesthesia, assessed up to 2 days
The duration of surgery
Time frame: From the date of the beginning of surgery until the date of the end of surgery, assessed up to 2 days
Time until awake
Time frame: From the end of anesthesia until awake, assessed up to 2 days
Time to removal of tracheal intubation
Time frame: From the end of anesthesia until the time of removal of tracheal intubation, assessed up to 2 days
Incidence of postoperative nausea and vomiting
Time frame: 48 hours after the surgery
Incidence of postoperative delirium
Time frame: 48 hours after the surgery
Incidence of hypoxemia
Time frame: 48 hours after the surgery
Postoperative first analgesia demand
Time frame: From the end of anesthesia until the date of first demand of analgesia drugs, assessed up to 1 week
numerical rating scale (NRS) pain score
Time frame: 24 hours and 48 hours after the surgery
Postoperative hospital stay
Time frame: From the date of the surgery until the date being discharged from hospital, up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-ketamine and Sufentanil in people with Opioid Use, Unspecified and S-ketamine, run by The First Affiliated Hospital with Nanjing Medical University 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ling Zhou (+86 15895918786, lingzhou531@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The probability of numerical rating scale (NRS) score being less than or equal to 3 when leaving the Postanesthesia Care Unit (PACU) (time frame: 1 day of the surgery). 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 20 Jul 2022.