Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05635955
Other study ID # MCHH_001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 1, 2022
Est. completion date September 30, 2022

Study information

Verified date November 2022
Source Maternal and Child Health Hospital of Hubei Province
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the efficacy and safety of propofol vs. remimazolam in combine use of esketamine in women with early pregnancy undergoing painless abortion. The main questions it aims to answer are: - whether remimazolam plus esketamine (R+E) has a better sedative and analgesic effectiveness than propofol plus esketamine (P+E). - whether R+E has less adverse events than P+E. Participants will be randomly allocated to two groups: R+E and P+E group. - For those in group R+E: they will be administered with 0.3mg/kg remimazolam and 0.3mg/kg esketamine before the abortion surgery. - For those in group P+E: they will be administered with 2mg/kg propofol and 0.3mg/kg esketamine before the abortion surgery. We will compare R+E with P+E to see if the time to loss of conscious and time to recover from the sedation will be shorter and if there will be less severe adverse events in R+E.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - early intrauterine pregnancy less than 12 weeks confirmed by transabdominal ultrasound and blood HCG - the American Society of Anesthesiologists (ASA) physical status ranked I-II - competent to provide informed consent Exclusion Criteria: - chronic pain - psychiatric disorders - liver or kidney failure - severe metabolic disorders - poor respiratory functions - cardiovascular diseases

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Remimazolam
Total intravenous anaesthesia will be induced with 0.3mg/kg remimazolam and 0.3mg/kg esketamine, slow injection. During the painless abortion surgery, if the MOAA/S scores > 1 or body movements occur, supplemental 0.2 mg/kg remimazolam (IV) will be administrated.
Propofol
Total intravenous anaesthesia will be induced with 2mg/kg propofol and 0.3mg/kg esketamine, slow injection. During the painless abortion surgery, if the MOAA/S scores > 1 or body movements occur, supplemental 0.25 mg/kg propofol (IV) will be administrated.
Esketamine
0.3mg/kg esketamine will be co-administrated in both arms

Locations

Country Name City State
China Maternal and Child Health Hospital of Hubei Province Wuhan Hubei

Sponsors (2)

Lead Sponsor Collaborator
Maternal and Child Health Hospital of Hubei Province The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to loss of consciousness The time from the study drug administration to loss of consciousness 5 - 30 minutes
Secondary Success rate of sedation Defined as completing the induction of anesthesia without an additional dosage Intraoperative period, 30 minutes - 1.5 hours
Secondary Recovery time Time to fully awake, defined as by a modified Aldrete score which will be recorded every 3 minutes from the end of the procedure with a recovery index (MAS) of 9 or more. Postoperative 30 minutes
Secondary Mean arterial pressure (MAP) MAP level will be monitored and recorded at 4 time points, including the entry into the operation room (Time 0), in sedation when vaginal dilator is placed (Time 1), in sedation when curettage begins (Time 2), and postoperative awakening (Time 3). Intraoperative period, 30 minutes - 1.5 hours
Secondary Heart rate (HR) HR will be monitored and recorded at 4 time points, including the entry into the operation room (Time 0), in sedation when vaginal dilator is placed (Time 1), in sedation when curettage begins (Time 2), and postoperative awakening (Time 3). Intraoperative period, 30 minutes - 1.5 hours
Secondary Adverse events The adverse events will be monitored and recorded during the operation and post-operation. AE will include: respiratory depression (defined as SpO2< 95%), hypotension (defined as systolic arterial pressure < 80 mmHg, or decreased baseline systolic blood pressure > 20%), hypertension, bradycardia (defined as decrease in HR < 50/min), number of body movements, injection site pain and nausea and vomiting. Intraoperative and post-operation, 30 minutes - 1.5 hours
Secondary Post-operative pain It will be assessed by Visual Analogue Scale (VAS) pain score. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Post-operation after fully awake, 30 minutes - 1 hour
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas