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Completed

NCT Number: NCT05223907

Safety and Efficacy of Maintenance of Etomidate in General Anesthesia

This study was designed to use etomidate combined with sevoflurane intravenously to maintain anesthesia process under the monitoring of BIS. Propofol was used as the controls. Blood pressure and heart rate were recorded during operation. The VAS pain score was observed after surgery.To investigate whether this program can better maintain intraoperative hemodynamic stability, improve the quality of recovery, and reduce the incidence of postoperative adverse reactions.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 ≤age≤65;
  • Types of surgery: laparoscopic gynecological surgery, laparoscopic gastrointestinal surgery, thoracoscopic radical lung cancer surgery;
  • 1 h ≤ operation time ≤ 3 h;
  • ASA grade I~III;
  • BMI of 18.5~29.9 kg/m2 [BMI= weight (kg)/height (m) 2] (2013 American guidelines for the Management of Overweight and Obesity in Adults);
  • In accordance with ethics, the patient voluntarily took the test and signed the informed consent.

Exclusion criteria

  • Cerebral vascular accident, such as stroke, transient ischemic attack (TIA), etc. within 3 months;
  • Severe abnormal liver and kidney function (severe abnormal liver function: ALT, AST, ALP, total bilirubin, one of which is more than 2 times the upper limit of normal value. Severe renal dysfunction: creatinine > 2 times upper normal);
  • Patients with diabetic complications (diabetic ketoacidosis, hyperotonic coma, various infections, macrovascular disease, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.);
  • Unstable angina pectoris or myocardial infarction occurred within 3 months;
  • Preoperative blood pressure ≥160/100 mmHg ( ≥ Grade 2 hypertension, 2020 ISH Hypertension Guidelines);
  • Identified/suspected abuse or long-term use of narcotic sedatives and analgesics; •Taking hormones or other immunosuppressive agents for more than 10 days within half a year, or having a history of adrenocortical suppression or immune system diseases;
  • Hypothyroidism;
  • Patients with a history of asthma;
  • Those who were reoperated within 3 months;
  • Having contraindications or allergies to test drugs and other narcotic drugs;
  • Patients enrolled in other studies within 30 days.

Treatment and study plan

Etomidate

Drug

Etomidate will be used for general anesthesia

Other names: Etomidate Injectable Emulsion, Yituomizhi, H20020511, WS-400(X-338)-2002-2015Z,YT211101

Propofol

Drug

Propofol will be used for general anesthesia

Other names: Diprivan, JX20060102,H20080473,RW981

Primary outcomes

  1. Rate of intraoperative hypertension and hypotension

    Time frame: From the beginning to the end of surgery

    Investigators will record the rate of hypertension and hypotension of participants during intraoperative period

  2. Ricker sedation-agitation score after surgery

    Time frame: 1 day (The period during patients wake up after surgery and general anesthesia in the recovery room.)

    Investigators will record the Ricker sedation-agitation score of participants during recovery period after general anestesia

Secondary outcomes

  1. Postoperative pain scores measured by VAS score.

    Time frame: One-three days after surgery.

    Postoperative pain scores of participants will be assessed by using VAS score (0= no pain, 10= worse pain imaginable)

  2. The incidence of PONV

    Time frame: One-three days after surgery.

    The incidence of postoperative nausea and vomiting of participants will be recorded

Sponsors and collaborators

Lead sponsor

Henan Provincial People's Hospital

Other

Registry information

Official study title

Safety and Efficacy of Maintenance of Etomidate Combined With Sevoflurane in General Anesthesia: a Multi-center Randomized Controlled Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2022
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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