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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group P | Placebo Comparator | Intravenous injection of an equivalent dose of normal saline followed by 2 mg/kg of propofol |
|
| group PK1 | Experimental | Intravenous injection of 0.5 mg/kg esketamine followed by 1.5 mg/kg of propofol |
|
| group PK2 | Experimental | Intravenous injection of 0.25 mg/kg esketamine followed by 1.5 mg/kg of propofol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous injection of propofol only | Drug | Propofol was administered intravenously 2 mg/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Rate | The respiratory rate (RR) was monitored from 3-lead ECG | 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 | 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 | 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 | Immediately upon entering the operating room and 5 minutes after injection of anesthetics |
| Measure | Description | Time Frame |
|---|---|---|
| number of additional propofol usage | The number of additional propofol was recorded | 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 |
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Inclusion Criteria：
Exclusion Criteria:
cervical lesions
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| Name | Affiliation | Role |
|---|---|---|
| Gang Y Hao | First Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30243294 | Background | 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. | |
| 38117498 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2022 | Aug 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 1, 2022 | Aug 22, 2024 | ICF_001.pdf |
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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.
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| intravenous injection of propofol +esketamine |
| Drug |
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 |
|
The postoperative awakening time (MOAA/S score >4) was recorded
| 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 | 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 | 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 |
| 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. |
| 31261820 | Background | 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. |
| 31860599 | Background | 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. |
| 29661389 | Background | 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. |
| 37430293 | Background | 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. |
| 31593791 | Background | 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. |