Combined Use of Etomidate and Propofol in Painless Gastroscopy.

Combined Use of Etomidate and Propofol in Painless Gastroscopy, a Multiple Center, Double Blinded, Randomized,Controled Study.

Gastroscopy, as a conventional examination for gastrointestinal tract disease, plays a very important role especially in early diagnosis and differential diagnosis of esophageal and gastric carcinoma. However, conventional gastroscopy is associated with several adverse effects (including throat discomfort, breath-holding, nausea, vomiting, laryngeal spasm and increased heart rate) due to which some patients are intolerant to this examination or even refuse the procedure due to fear of these effects. Recently, painless gastroscopy has been applied increasingly widely in outpatients to meet the increasing needs for comfortable medical care.

Painless gastroscopy is commonly performed under general anesthesia without establishing an artificial airway. This is associated with an even higher anesthetic risk than general anesthesia in the operating room due to more basic patient monitoring and life-supporting equipment, only one anesthetist to perform anesthesia, fatigue in anesthesia, the requirement for a high turnover rate, as well as limited understanding of a patient's condition. Therefore, the availability of sedatives and analgesics which can provide rapid onset, sufficient sedation and analgesia, a short recovery time and less adverse effects are the premise of performing painless gastroscopy. Currently, combined intravenous anesthesia with fentanyl and propofol, commonly used in the clinic, is still associated with a long duration of action, hypotension in some patients and prolonged recovery. Etomidate has been increasingly utilized for in-clinic diagnosis and treatment for procedures such as painless coloscopy and early induced abortion due to its rapid onset, rapid metabolism and minimal impact on the circulatory and respiratory systems. However, no study on combined intravenous anesthesia with fentanyl and etomidate for painless gastroscopy had previously been reported. The main purpose of this study is to explore the efficacy and safety of combined intravenous anesthesia with fentanyl and etomidate for painless gastroscopy compared with the combination of fentanyl and propofol in middle aged and elderly patients, and to provide reliable evidence for the implementation and promotion of comfortable medical care.

Study Overview

• Status: Unknown
• Conditions: Safety of Gastroscopy
• Intervention / Treatment: Drug: Fentanyl Injection; Drug: Propofol Injection; Drug: Etomidate Fat Emulsion Injection

Detailed Description

There are 6 centers for this trial: General Hospital of Chinese People's Liberation Army, Chaoyang Hospital Attached to the Capital Medical University, The Second Affiliated Hospital of Harbin Medical University, Renmin Hospital of Wuhan University Hubei General Hospital, The Affiliated Hospital of Xuzhou Medical College, Hospital of Chinese Air Force.

• Study Type: Interventional
• Enrollment (Anticipated): 2450
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Weidong Mi, Senior; Phone Number: +86-13381082966; Email: wwdd1962@yahoo.com.cn

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100020
      • Not yet recruiting
      • Chaoyang Hospital Attached to the Capital Medical University
      • Contact: Anshi Wu; Phone Number: 13511010883
      • Principal Investigator: Anshi Wu
    • Peking, Beijing, China, 100036
      • Not yet recruiting
      • General Hospital of Chinese Air Force
      • Contact: Xiaodong Xue; Phone Number: 13311161680
      • Principal Investigator: Xiaodong Xue
    • Peking, Beijing, China, 100853
      • Completed
      • General Hospital of Chinese People's Liberation Army
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150086
      • Recruiting
      • The Second Affiliated Hospital of Harbin Medical University
      • Contact: Jinfeng Liu; Phone Number: 15663488219; Email: 13936322563@126.com
      • Principal Investigator: Jinfeng Liu
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Renmin Hospital of Wuhan University Hubei General Hospital
      • Contact: Xingpeng Xiao; Phone Number: 18971227731
      • Principal Investigator: Xingpeng Xiao
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221006
      • Not yet recruiting
      • The Affiliated Hospital of Xuzhou Medical College
      • Principal Investigator: Lei Chen
      • Contact: Lei Chen; Phone Number: 13905202758

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Preparing to take gastroscopy;
• Age:between 45 to 75 years old (middle-aged group: 45~59 years old; elderly group: 60~75 years old; the percentage of middle-aged group and elderly group are 60% and 40%, respectively);
• BMI: between 18 to 25 kg/m2;
• ASA classification: grade Ⅰ~Ⅱ.

Exclusion Criteria:

• Blood pressure before operation: >180 mm Hg or <90 mm Hg;
• ECG before operation: <50 beats per min;
• HGB before operation: <90 g/L;
• Infected with respiratory inflammation and not cured within 2 weeks;
• Sever heart, brain, pulmonary, heptic, renal diseases or diabetes;
• History of difficult airway or abnormal recovery from anesthesia before or difficult airway is predicted to occur ;
• Obvious electrolyte disturbance such as hyperkalemia;
• Treated with immunosuppressants such as hormones for a long time or prior inhibition of the adrenal cortex;
• Allergic to emulsion or opioids;
• Concomitant other sedatives or analgesics (including injectable or oral administration of treatment related to Chinese Traditional Patent Medicines);
• Suspected abuse of narcotic analgesics or sedatives;
• Patients for whom it is difficult to cooperate or communicate because of abnormalities of neuromuscular system or mental disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fentanyl & Propofol; 0.02 ml/kg(1 μg/kg) fentanyl is diluted to 10 ml with normal saline and infused within 1 min, 4 min advance. 0.5 mg/kg(0.025 ml/kg) propofol is infused within 15 to 20 s. And then, depending on the randomized result, 0.5 mg/kg is given every time until the patient falls asleep. During the operation, 0.5 mg/kg is given when it is needed.	Drug: Fentanyl Injection; Drug: Propofol Injection; Other Names: Jing'an
Experimental: fentanyl, propofol & etomidate; 0.02 ml/kg(1 μg/kg) fentanyl is diluted to 10 ml with normal saline and infused within 1 min, 4 min advance. 0.5 mg/kg(0.025 ml/kg) propofol is infused within 15 to 20 s. And then, depending on the randomized result, 0.5 mg/kg etomidate is given every time until the patient falls asleep. During the operation, 0.5 mg/kg etomidate is given when it is needed.	Drug: Fentanyl Injection; Drug: Propofol Injection; Other Names: Jing'an; Drug: Etomidate Fat Emulsion Injection; Other Names: Fuerli

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Changes of blood pressure in each group will be recorded.	baseline to 10 min after the operation, an expected average of 20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Changes of heart rate in each group will be recorded.	baseline to the end of the operation, an expected average of 30 minutes
Pulse Oxygen Saturation	Changes of pulse oxygen saturation in each group will be recorded.	baseline to the end of the operation, an expected average of 10 minutes
Respiratory rate	Changes of respiratory rate in each group will be recorded	baseline to the end of the operation, an expected average of 10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of anesthesia	The time when propofol is given is defined as the time when infusion of propofol is beginning. The time of discharge is defined as the time when Steward score of the patient ≥4.	From the time when propofol is given to discharge, an expected average of 30 minutes
Satisfaction	Record the satisfaction from the operator, the anesthetist and the patients	10 minutes after the operation
Recovery of anesthesia	Steward score was used to evaluate the recovery of anesthesia.	10 min, 15 min and 15 min after the operation
Recovery of orientation	MMSE scale is used to evaluate the recovery of orientation for each patient.	10 min, 15 min and 20 min after the operation
Comfort degree		10 minutes after the operation
Adverse events		during the operation, an expected average of 10 minutes

Collaborators and Investigators

• Sponsor: Jiangsu Nhwa Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Weidong Mi, Senior, General Hospital of Chinese People's Liberation Army

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: July 25, 2013
• First Submitted That Met QC Criteria: July 29, 2013
• First Posted (Estimate): July 31, 2013

Study Record Updates

• Last Update Posted (Estimate): December 16, 2013
• Last Update Submitted That Met QC Criteria: December 13, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Propofol; Etomidate; Painless gastroscopy
• 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: 2013072201