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

NCT01729897 | Completed DMC

• 1 other identifier: ChiCTR-TRC-20121001
• Study Type: interventional
• Target: 328
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Complication of Gastrostomy

Keywords

gastroscopy; sedation; etomidate

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

Other Outcomes (3)

• 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

Study Arms (2)

Etomidate & Fentanyl

EXPERIMENTAL

* 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: Etomidate; Drug: Fentanyl

Propofol & Fentanyl

PLACEBO COMPARATOR

* 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

Interventions

Etomidate DRUG

Etomidate & Fentanyl

Fentanyl DRUG

Etomidate & Fentanyl; Propofol & Fentanyl

Propofol DRUG

Propofol & Fentanyl

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for painless gastroscopy
• year old
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Nhwa Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

Etomidate; Fentanyl; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: November 20, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 13, 2013

Record last verified: 2013-05