EsketaminePhase 4ESK，LEEPNCT06574945

Anesthesia for Loop Electrosurgical Excision Procedure (LEEP).

A Phase 4 study testing intravenous injection of propofol only and intravenous injection of propofol +esketamine in people with Esketamine and Loop Electrosurgical Excision, run by Qian Wu at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Esketamine, Loop Electrosurgical Excision, Propofol
What is being tested?: intravenous injection of propofol only and intravenous injection of propofol +esketamine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteChina
Study dates: 7 Jan 2022to 28 Oct 2022
Phase: Phase 4
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 20 to 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Patients who will undergo Loop Electrosurgical Excision Procedure
The age of the patients ranged from 20 to 60 years old
Paients had a BMI of 18-30 kg/m2
ASA physical status grade of I or II

Who cannot join

Patients who refused to participate
History of hypertension, hyperthyroidism, or neurological or mental disorder
Currently taking or has taken opioids and non-steroidal anti-inflammatory drugs within 48 h before surgery
Participated in other drug clinical trials within 4 weeks
Allergy to esketamine or propofol
History of opioid or esketamine addiction

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality

Other trials in China

About this study

Official title: Efficacy and Safety of Propofol in Combination With Different Esketamine Doses for Anesthesia During Loop Electrosurgical Excision Procedure

The goal of this prospective, randomized controlled study study is to investigate the efficacy and safety of propofol combined with different doses of esketamine (ESK) for anesthesia during loop electrosurgical excision procedure (LEEP).Ninety female patients undergoing LEEP were randomly allocated to three groups.It aims to answer :1.The effect of esketamine combined with propofol in respiration, circulation, etc,during LEEP. 2.The appropriate dosage of esketamine when combined with propofol in LEEP anesthesia.

Read the detailed description

To investigate the efficacy and safety of propofol combined with different doses of esketamine (ESK) for anesthesia during loop electrosurgical excision procedure (LEEP). Ninety female patients undergoing LEEP were randomly allocated to three groups: group P (2 mg/kg propofol + saline), group propofol + esketamine(PK)1 (1.5 mg/kg propofol + 0.5 mg/kg ESK), and group PK2 (1.5 mg/kg propofol + 0.25 mg/kg ESK). Parameters including mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), oxygen saturation (SPO2), and venous carbon dioxide (PvCO2) were recorded. Additionally, the need for supplemental propofol, jaw thrust maneuver or ventilation, postoperative awakening time, and adverse reactions were assessed.

Conditions: Esketamine, Loop Electrosurgical Excision, Propofol
Being tested: intravenous injection of propofol only, intravenous injection of propofol +esketamine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

intravenous injection of propofol onlyDrug
Propofol was administered intravenously 2 mg/kg
intravenous injection of propofol +esketamineDrug
intravenous injection of 0.5 mg/kg ESK followed by 1.5 mg/kg of propofol or intravenous injection of 0.25 mg/kg ESK followed by 1.5 mg/kg of propofol

Study groups in NCT06574945
Study group	Role	What they receive
group P	Placebo comparator	Intravenous injection of an equivalent dose of normal saline followed by 2 mg/kg of propofol Receives: Drug: intravenous injection of propofol only
group PK1	Experimental	Intravenous injection of 0.5 mg/kg esketamine followed by 1.5 mg/kg of propofol Receives: Drug: intravenous injection of propofol +esketamine
group PK2	Experimental	Intravenous injection of 0.25 mg/kg esketamine followed by 1.5 mg/kg of propofol Receives: Drug: intravenous injection of propofol +esketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

Respiratory Rate
The respiratory rate (RR) was monitored from 3-lead ECG
Measured: Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics
Heart Rate
The heart rate (HR) was monitored using 3-lead ECG
Measured: Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics
Mean Arterial Pressure
The mean arterial pressure (MAP) was monitored using Noninvasive blood pressure monitor
Measured: Immediately upon entering the operating room, 1 and 5 minutes after injection of anesthetics
Venous Carbon Dioxide
The venous carbon dioxide (PvCO2) was monitored using blood-gas analyzer
Measured: Immediately upon entering the operating room and 5 minutes after injection of anesthetics

Secondary outcomes (4)

number of additional propofol usage
The number of additional propofol was recorded
Measured: On the day of surgery, from the instant the anesthesia induction is completed to the instant completion of surgery,up to 10 minutes
postoperative awakening time
The postoperative awakening time (MOAA/S score >4) was recorded
Measured: On the day of surgery, from the instant completion of surgery to the moment the patient wakes up (when MOAA score >4),up to 10 minutes
number of jaw thrust maneuver or face mask ventilation
The number of jaw thrust maneuver or face mask ventilation was recorded
Measured: On the day of surgery, from the instant the anesthesia induction is completed to the instant completion of surgery,up to 10 minutes
incidences of postoperative vertigo, nausea, agitation and delirium
incidences of postoperative vertigo, nausea, agitation and delirium were recorded
Measured: On the day of surgery,from the moment the patient wakes up (when MOAA score >4) to the moment the patient leaving the recovery room,up to 30minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 202228 Oct 2022

First posted28 Aug 2024
Study start7 Jan 2022
Primary completion7 Jan 2022
Study completion28 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for EsketamineStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients were categorized into three groups: propofol (2 mg/kg) + normal saline (group P), propofol (1.5 mg/kg) + ESK (0.5 mg/kg) (group PK1), and propofol (1.5 mg/kg) + ESK (0.25 mg/kg) (group PK2). In group P, patients received an intravenous injection of an equivalent dose of normal saline followed by 2 mg/kg of propofol. Group PK1 received an intravenous injection of 0.5 mg/kg ESK followed by 1.5 mg/kg of propofol. Similarly, group PK2 received an intravenous injection of 0.25 mg/kg ESK followed by 1.5 mg/kg of propofol.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06574945
Sponsor's protocol ID: 2022-71
Acronym: ESK，LEEP
Status last verified: Aug 2024
First submitted: 20 Aug 2024
Last updated: 28 Aug 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yan T, Zhang GH, Wang BN, Sun L, Zheng H. Effects of propofol/remifentanil-based total intravenous anesthesia versus sevoflurane-based inhalational anesthesia on the release of VEGF-C and TGF-beta and prognosis after breast cancer surgery: a prospective, randomized and controlled study. BMC Anesthesiol. 2018 Sep 22;18(1):131. doi: 10.1186/s12871-018-0588-3.
PubMed 30243294
Song N, Yang Y, Zheng Z, Shi WC, Tan AP, Shan XS, Liu H, Meng L, Peng K, Ji FH. Effect of Esketamine Added to Propofol Sedation on Desaturation and Hypotension in Bidirectional Endoscopy: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2347886. doi: 10.1001/jamanetworkopen.2023.47886.
PubMed 38117498
Oh C, Kim Y, Eom H, Youn S, Lee S, Ko YB, Yoo HJ, Chung W, Lim C, Hong B. Procedural Sedation Using a Propofol-Ketamine Combination (Ketofol) vs. Propofol Alone in the Loop Electrosurgical Excision Procedure (LEEP): A Randomized Controlled Trial. J Clin Med. 2019 Jun 28;8(7):943. doi: 10.3390/jcm8070943.
PubMed 31261820
Eberl S, Koers L, van Hooft J, de Jong E, Hermanides J, Hollmann MW, Preckel B. The effectiveness of a low-dose esketamine versus an alfentanil adjunct to propofol sedation during endoscopic retrograde cholangiopancreatography: A randomised controlled multicentre trial. Eur J Anaesthesiol. 2020 May;37(5):394-401. doi: 10.1097/EJA.0000000000001134.
PubMed 31860599
Jonkman K, van Rijnsoever E, Olofsen E, Aarts L, Sarton E, van Velzen M, Niesters M, Dahan A. Esketamine counters opioid-induced respiratory depression. Br J Anaesth. 2018 May;120(5):1117-1127. doi: 10.1016/j.bja.2018.02.021. Epub 2018 Mar 26.
PubMed 29661389
Nie J, Chen W, Jia Y, Zhang Y, Wang H. Comparison of remifentanil and esketamine in combination with propofol for patient sedation during fiberoptic bronchoscopy. BMC Pulm Med. 2023 Jul 11;23(1):254. doi: 10.1186/s12890-023-02517-1.
PubMed 37430293
Trujillo KA, Heller CY. Ketamine sensitization: Influence of dose, environment, social isolation and treatment interval. Behav Brain Res. 2020 Jan 27;378:112271. doi: 10.1016/j.bbr.2019.112271. Epub 2019 Oct 5.
PubMed 31593791

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
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Not yet recruitingPhase 4
Effect of Low-Dose Esketamine Combined With Dexmedetomidine on the Incidence of Chronic Postsurgical Pain in Patients Undergoing Pancreatic Surgery
Chronic Pain, Postoperative
Not yet recruitingPhase 4
Perioperative Esketamine Safety and Efficacy in Reducing Postoperative ENDometriosis PAIN (the ENDPAIN Trial): a Randomized Controlled Trial.
Endometriosis
Not yet recruiting
Intranasal Dexmedetomidine Combined With Esketamine for Emergence Quality After Suspension Laryngoscopy
Emergence Agitation, Vocal Cord Polyps
Active, not recruiting
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All Esketamine trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Propofol in Combination With Different Esketamine Doses for Anesthesia During Loop Electrosurgical Excision Procedure
ClinicalTrials.gov ID: NCT06574945
Acronym / sponsor ID: ESK，LEEP / 2022-71
Conditions: Esketamine, Loop Electrosurgical Excision, Propofol
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Qian WuUniversity, hospital or other
Study start: 7 Jan 2022 (actual)
Primary completion: 7 Jan 2022 (actual)
Study completion: 28 Oct 2022 (actual)
First posted: 28 Aug 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Patients were categorized into three groups: propofol (2 mg/kg) + normal saline (group P), propofol (1.5 mg/kg) + ESK (0.5 mg/kg) (group PK1), and propofol (1.5 mg/kg) + ESK (0.25 mg/kg) (group PK2). In group P, patients received an intravenous injection of an equivalent dose of normal saline followed by 2 mg/kg of propofol. Group PK1 received an intravenous injection of 0.5 mg/kg ESK followed by 1.5 mg/kg of propofol. Similarly, group PK2 received an intravenous injection of 0.25 mg/kg ESK followed by 1.5 mg/kg of propofol.

Arm	Type	Receives
group P	Placebo comparator	Drug: intravenous injection of propofol onlyIntravenous injection of an equivalent dose of normal saline followed by 2 mg/kg of propofol
group PK1	Experimental	Drug: intravenous injection of propofol +esketamineIntravenous injection of 0.5 mg/kg esketamine followed by 1.5 mg/kg of propofol
group PK2	Experimental	Drug: intravenous injection of propofol +esketamineIntravenous injection of 0.25 mg/kg esketamine followed by 1.5 mg/kg of propofol

Who may qualify

Ages: 20 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Patients who will undergo Loop Electrosurgical Excision Procedure
The age of the patients ranged from 20 to 60 years old
Paients had a BMI of 18-30 kg/m2
ASA physical status grade of I or II

Key exclusion criteria (6 listed)

Patients who refused to participate
History of hypertension, hyperthyroidism, or neurological or mental disorder
Currently taking or has taken opioids and non-steroidal anti-inflammatory drugs within 48 h before surgery
Participated in other drug clinical trials within 4 weeks
Allergy to esketamine or propofol

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
intravenous injection of propofol onlyPropofol was administered intravenously 2 mg/kg	Drug	group P
intravenous injection of propofol +esketamineintravenous injection of 0.5 mg/kg ESK followed by 1.5 mg/kg of propofol or intravenous injection of 0.25 mg/kg ESK followed by 1.5 mg/kg of propofol	Drug	group PK1, group PK2

Primary outcome

Respiratory Rate
Time frame: Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics
The respiratory rate (RR) was monitored from 3-lead ECG
Heart Rate
Time frame: Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics
The heart rate (HR) was monitored using 3-lead ECG
Mean Arterial Pressure
Time frame: Immediately upon entering the operating room, 1 and 5 minutes after injection of anesthetics
The mean arterial pressure (MAP) was monitored using Noninvasive blood pressure monitor
Venous Carbon Dioxide
Time frame: Immediately upon entering the operating room and 5 minutes after injection of anesthetics
The venous carbon dioxide (PvCO2) was monitored using blood-gas analyzer

4 secondary outcomes

number of additional propofol usage
Time frame: On the day of surgery, from the instant the anesthesia induction is completed to the instant completion of surgery,up to 10 minutes
postoperative awakening time
Time frame: On the day of surgery, from the instant completion of surgery to the moment the patient wakes up (when MOAA score >4),up to 10 minutes
number of jaw thrust maneuver or face mask ventilation
Time frame: On the day of surgery, from the instant the anesthesia induction is completed to the instant completion of surgery,up to 10 minutes
incidences of postoperative vertigo, nausea, agitation and delirium
Time frame: On the day of surgery,from the moment the patient wakes up (when MOAA score >4) to the moment the patient leaving the recovery room,up to 30minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
Background: PubMed 30243294Yan T, Zhang GH, Wang BN, Sun L, Zheng H. Effects of propofol/remifentanil-based total intravenous anesthesia versus sevoflurane-based inhalational anesthesia on the release of VEGF-C and TGF-beta and prognosis after breast cancer surgery: a prospective, randomized and controlled study. BMC Anesthesiol. 2018 Sep 22;18(1):131. doi: 10.1186/s12871-018-0588-3.
Background: PubMed 38117498Song N, Yang Y, Zheng Z, Shi WC, Tan AP, Shan XS, Liu H, Meng L, Peng K, Ji FH. Effect of Esketamine Added to Propofol Sedation on Desaturation and Hypotension in Bidirectional Endoscopy: A Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2347886. doi: 10.1001/jamanetworkopen.2023.47886.
Background: PubMed 31261820Oh C, Kim Y, Eom H, Youn S, Lee S, Ko YB, Yoo HJ, Chung W, Lim C, Hong B. Procedural Sedation Using a Propofol-Ketamine Combination (Ketofol) vs. Propofol Alone in the Loop Electrosurgical Excision Procedure (LEEP): A Randomized Controlled Trial. J Clin Med. 2019 Jun 28;8(7):943. doi: 10.3390/jcm8070943.
Background: PubMed 31860599Eberl S, Koers L, van Hooft J, de Jong E, Hermanides J, Hollmann MW, Preckel B. The effectiveness of a low-dose esketamine versus an alfentanil adjunct to propofol sedation during endoscopic retrograde cholangiopancreatography: A randomised controlled multicentre trial. Eur J Anaesthesiol. 2020 May;37(5):394-401. doi: 10.1097/EJA.0000000000001134.
Background: PubMed 29661389Jonkman K, van Rijnsoever E, Olofsen E, Aarts L, Sarton E, van Velzen M, Niesters M, Dahan A. Esketamine counters opioid-induced respiratory depression. Br J Anaesth. 2018 May;120(5):1117-1127. doi: 10.1016/j.bja.2018.02.021. Epub 2018 Mar 26.
Background: PubMed 37430293Nie J, Chen W, Jia Y, Zhang Y, Wang H. Comparison of remifentanil and esketamine in combination with propofol for patient sedation during fiberoptic bronchoscopy. BMC Pulm Med. 2023 Jul 11;23(1):254. doi: 10.1186/s12890-023-02517-1.
Background: PubMed 31593791Trujillo KA, Heller CY. Ketamine sensitization: Influence of dose, environment, social isolation and treatment interval. Behav Brain Res. 2020 Jan 27;378:112271. doi: 10.1016/j.bbr.2019.112271. Epub 2019 Oct 5.
Individual participant dataSharing planned: No

Related trials for Esketamine

Not yet recruitingPhase 2
Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
Suicidal Ideation, Suicidal Behavior
Not yet recruitingPhase 4
Effect of Low-Dose Esketamine Combined With Dexmedetomidine on the Incidence of Chronic Postsurgical Pain in Patients Undergoing Pancreatic Surgery
Chronic Pain, Postoperative
Not yet recruitingPhase 4
Perioperative Esketamine Safety and Efficacy in Reducing Postoperative ENDometriosis PAIN (the ENDPAIN Trial): a Randomized Controlled Trial.
Endometriosis
Not yet recruiting
Intranasal Dexmedetomidine Combined With Esketamine for Emergence Quality After Suspension Laryngoscopy
Emergence Agitation, Vocal Cord Polyps
Active, not recruiting
Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients
Gastrointestinal Disease

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.

Gang Y Hao principal investigator

First Affiliated Hospital of Chongqing Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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: finished, as of the sponsor's last update on 28 Aug 2024. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Respiratory Rate (time frame: Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06574945, which also lists 7 linked publications.

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 28 Aug 2024.