Clinical trial NCT01729897: Etomidate Emulsion for Sedation in Patients Scheduled for Upper Gastrointestinal (GI) Endoscopy
Official title: A Multicenter Open-label Randomized Controlled Clinical Trial of Etomidate Emulsion for Sedation in Patients Scheduled for Upper GI Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complication of Gastrostomy
Keywords: gastroscopy
sedation
etomidate
Lead sponsor: Jiangsu Nhwa Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-11-20
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: the minimum blood pressure
timeFrame: 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
measure: the proportion of hypotension
timeFrame: 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
measure: the minimum oxygen saturation of blood
timeFrame: 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
measure: Time interval
timeFrame: from the last administration of etomidate to when the patient leave the hospital
Secondary outcomes:
measure: Incidence rate of the side effects
timeFrame: participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours
measure: the cost of the experiment drug
timeFrame: the money that the participants spend from the beginning of the surgery to leaving hospital，an expected average of 4 hours
Other outcomes:
measure: Other adverse events except above
timeFrame: participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours
measure: the changes of the primary clinical symptoms
timeFrame: participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours
measure: the abnormal laboratory examinations
timeFrame: participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours
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