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

Sponsors

Lead Sponsor: Jiangsu Nhwa Pharmaceutical Co., Ltd.

Source Jiangsu Nhwa Pharmaceutical Co., Ltd.
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.

Overall Status Completed
Start Date May 2012
Completion Date October 2012
Primary Completion Date August 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure 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 from the last administration of etomidate to when the patient leave the hospital
Secondary Outcome
Measure Time Frame
Incidence rate of the side effects 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
Enrollment 328
Condition
Intervention

Intervention Type: Drug

Intervention Name: Etomidate

Arm Group Label: Etomidate & Fentanyl

Intervention Type: Drug

Intervention Name: Fentanyl

Intervention Type: Drug

Intervention Name: Propofol

Arm Group Label: Propofol & Fentanyl

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Verification Date

May 2013

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Etomidate & Fentanyl

Type: Experimental

Description: 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.

Label: Propofol & Fentanyl

Type: Placebo Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov