NCT03855267

Brief Summary

The purpose of this study was to investigate the effects of different proportions of etomidate/propofol mixture and propofol alone intravenous anesthesia on intraoperative and postoperative physiological indicators and complications, and to find out the optimal use ratio of E/P mixture.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

February 24, 2019

Last Update Submit

February 25, 2019

Conditions

Etomidate is Mixed With Propofol

Keywords

propofoletomidateGeneral anesthesiamixture

Outcome Measures

Primary Outcomes (2)

  • blood pressure

    the blood pressure is recorded (mmHg)

    intraoperative

  • heart rate

    the heart rate is recorded(bpm)

    intraoperative

Secondary Outcomes (1)

  • Perioperative complications

    intraoperative

Other Outcomes (1)

  • Recovery time

    intraoperative

Study Arms (4)

Group A

PLACEBO COMPARATOR

Propofol 20 mg/ml, recommended anesthesia induction dose of 0.1\~0.125 ml/kg, anesthesia maintenance pump speed of 0.2\~0.5ml/kg/h. keep bispectral index within 40 # 60

Drug: Propofol 20 MG/ML

GroupB

ACTIVE COMPARATOR

EP1:3, that is, 10ml etomidate was mixed with 30ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml.

Drug: Propofol 20 mg/ml , etomidate 2 mg/ml

Group C

ACTIVE COMPARATOR

EP1:1, that is, 20ml etomidate was mixed with 20ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml.

Drug: Propofol 20 mg/ml , etomidate 2 mg/ml

Group D

ACTIVE COMPARATOR

EP3:1, that is, 30ml etomidate was mixed with 10ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml.

Drug: Propofol 20 mg/ml , etomidate 2 mg/ml

Interventions

Propofol 20 MG/MLDRUG

Pump propofol to keep bispectral index within 40 # 60

Group A
Propofol 20 mg/ml , etomidate 2 mg/mlDRUG

Propofol was mixed with etomidate in different proportions.keep bispectral index within 40 # 60.

Group CGroup DGroupB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective general anesthesia surgery in 3h;
  • American Society of Anesthesiologists gradesâ… \~III;
  • Aged 18 to 65 years, Body Mass Index 18.5 \~ 29.9kg / m2;
  • Hemoglobin 100 \~ 125g / L.
  • In line with the ethics, the patients volunteered to take the test and signed the informed consent

You may not qualify if:

  • Identify or suspect abuse or chronic use of narcotic sedatives and analgesics;
  • Heart, or liver, or lung, or kidney dysfunction;
  • Body mass index\> 30kg / m2; or \<18.5kg / m2
  • Speech, hearing or mental disorders;
  • severe diabetes, hyperkalemia ;
  • participate in other drug clinical researches in four weeks;
  • Poor compliance, can not complete clinical research by research program.
  • Any cerebrovascular accident occurred within 3 months, such as stroke, TIA, etc
  • Unstable angina and myocardial infarction occurred within 3 months;
  • Having contraindications or allergies to experimental drugs and other narcotic drugs;
  • Mental illness, hyperkalemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zicheng Wang

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Interventions

PropofolEtomidate

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Guolin Wang, MD.PHD

    Tainjin Medical University General Hospita

    STUDY DIRECTOR

Central Study Contacts

Zicheng Wang, MM

CONTACT

13821112922527640484@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Tianjin Medical University General Hospital

Study Record Dates

First Submitted

February 24, 2019

First Posted

February 26, 2019

Study Start

January 1, 2019

Primary Completion

October 31, 2019

Study Completion

December 1, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

CN(1)