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

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

Study Overview

• Status: Completed
• Conditions: Complication of Gastrostomy
• Intervention / Treatment: Drug: Fentanyl; Drug: Propofol; Drug: Etomidate

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.

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Etomidate & Fentanyl; 4 min before procedure: fentanyl 1 μg/kg (0.02 ml/kg), intravenous injection; After injection of fentanyl, etomidate was infused intravenously at rate of 200 ml/h for 30 seconds with unified injection pump, then after interval time of 30 seconds, infusion rate was altered to 500 ml/h and infusion was sustained until patients fell asleep.; Additional dose of etomidate would be administrated separately when duration of procedure was prolonged.	Drug: Fentanyl; Drug: Etomidate
PLACEBO_COMPARATOR: Propofol & Fentanyl; 4 min before procedure: fentanyl 1 g/kg (0.02 ml/kg), intravenous injection; After injection of fentanyl, propofol was infused intravenously at rate of 200 ml/h for 30 seconds with unified injection pump, then after interval time of 30 seconds, infusion rate was altered to 500 ml/h and infusion was sustained until patients fell asleep.; Additional dose of propofol would be administrated separately when duration of procedure was prolonged.	Drug: Fentanyl; Drug: Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the minimum blood pressure		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
the proportion of hypotension		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
the minimum oxygen saturation of blood		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
Time interval	the time interval that from the last administration of etomidate to when the patient leave the hospital	from the last administration of etomidate to when the patient leave the hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of the side effects	the side effects include dizziness，nausea，vomit，myoclonia，injection pain，and the awareness during operation	participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours
the cost of the experiment drug		the money that the participants spend from the beginning of the surgery to leaving hospital，an expected average of 4 hours

Other Outcome Measures

Outcome Measure	Time Frame
Other adverse events except above	participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours
the changes of the primary clinical symptoms	participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours
the abnormal laboratory examinations	participants will be followed for the duration from the beginning of the surgery to leaving hospital，an expected average of 4 hours

Collaborators and Investigators

• Sponsor: Jiangsu Nhwa Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: November 14, 2012
• First Posted (ESTIMATE): November 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 13, 2013
• Last Update Submitted That Met QC Criteria: May 10, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: sedation; gastroscopy; etomidate
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Propofol; Etomidate
• Other Study ID Numbers: ChiCTR-TRC-20121001