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Completed

NCT Number: NCT01729897

Etomidate Emulsion for Sedation in Patients Scheduled for Upper Gastrointestinal (GI) Endoscopy

The study is designed to explore and compare the efficacy and safety of etomidate and propofol with or without analgesic for painless gastroscopy, and to provide more reliant support for implementation and promotion of comfort care.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

To widely implement painless gastroscopy is required by diagnose and treatment with gastroscopy due to the large number and significant suffering of the patients. Also, development and exploration of anesthesiology will be bound to prompt the development and exploration of painless gastroscopy. However, the anesthesia risk of painless gastroscopy are usually higher than that of general anesthesia performed in operating room due to the condition, monitoring and equipments as well as the staffing for its implementation. Thus, the finding of a safe and convenient approach for general anesthesia will have a profound impact on a full promotion and implementation of comfortable care.

Etomidate, with the main advantage of little effect on circulatory and respiratory systems, and the features of rapid onset and metabolism, may be helpful to guarantee the safety of painless diagnosis and treatment, thus appropriate for the procedure with short duration of anesthesia. However, there is controversy regarding whether analgesic should be used in combination, as well as how to given the combined regimen.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for painless gastroscopy
  • 18-80 year old
  • 18 H2 ≤ weight ≤ 35 H2 (H indicates height)
  • American Society of Anesthesiologists (ASA) physical status class 1-3
  • The duration of surgery is ≤ 60 min ( duration of surgery was defined as the interval time from insert to withdraw of catheter)
  • Without liver, kidney and heart disease history
  • No previous history of abnormal recovery of anesthesia in surgery

Exclusion criteria

  • Patients whom do not wish to perform painless gastroscopy or participate in the study
  • Patients with medical history of severe heart, lung, liver, kidney or metabolic disease
  • Patients with abnormal ECG presented as heart rate 50 < beat/min
  • Patients who suffered from acute inflammation of respiratory tract within the past 2 weeks and did not be cured of it before participating in the study
  • Hypertension patient with preoperative blood pressure > 180/90 mmHg; hypotension patients with preoperative blood pressure < 90/60 mmHg;
  • Patients with neuromuscular disease, mental disorders
  • Hemoglobin is less than 90 g/L
  • Patients with suspected abuse of Anesthesia and Analgesia
  • Patients who were predicted to have or had previous difficult airway ( difficult airway is defined as the clinical situation in which a conventionally trained anesthesiologist experiences three failures of intubation)
  • Patients with known emulsion or opioid allergy
  • Patients who will be noncompliant or unable to communicate
  • Patients who received long-term treatment with hormone or had history of adrenocortical suppression
  • Patients received coadministration of other sedative, analgesic ( including injection, oral or usage of relevant Chinese patent medicine) before, during or 15 min after the procedure
  • Patients who appeared nausea and vomit, dizziness
  • Patients with sever diabetes mellitus, hyperkaliemia or significant electrolyte disturbances

Treatment and study plan

Etomidate

Drug

Fentanyl

Drug

Propofol

Drug

Primary outcomes

  1. the minimum blood pressure

    Time frame: participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours

  2. the proportion of hypotension

    Time frame: participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours

  3. the minimum oxygen saturation of blood

    Time frame: participants will be followed for the duration that from the beginning of the surgery to the extraction of the gastroscopy, an expected average of 2 hours

  4. Time interval

    Time frame: from the last administration of etomidate to when the patient leave the hospital

    the time interval that from the last administration of etomidate to when the patient leave the hospital

Secondary outcomes

  1. Incidence rate of the side effects

    Time frame: participants will be followed for the duration from the beginning of the surgery to leaving hospital,an expected average of 4 hours

    the side effects include dizziness,nausea,vomit,myoclonia,injection pain,and the awareness during operation

  2. the cost of the experiment drug

    Time frame: the money that the participants spend from the beginning of the surgery to leaving hospital,an expected average of 4 hours

Other outcomes

  1. Other adverse events except above

    Time frame: participants will be followed for the duration from the beginning of the surgery to leaving hospital,an expected average of 4 hours

  2. the changes of the primary clinical symptoms

    Time frame: participants will be followed for the duration from the beginning of the surgery to leaving hospital,an expected average of 4 hours

  3. the abnormal laboratory examinations

    Time frame: participants will be followed for the duration from the beginning of the surgery to leaving hospital,an expected average of 4 hours

Sponsors and collaborators

Lead sponsor

Jiangsu Nhwa Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter Open-label Randomized Controlled Clinical Trial of Etomidate Emulsion for Sedation in Patients Scheduled for Upper GI Endoscopy

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 20, 2012
Registry last updated
May 13, 2013

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.