Comparison of Desflurane Anesthesia Versus TIVA-TCI in Patients Undergoing Ophthalmic Ambulatory Surgery

NCT02922660 | Completed DMC

• 1 other identifier: ZOCMZK-2016
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, randomized, prospective research which aims to investigate the advantages and disadvantages between desflurane balanced anesthesia and TIVA-TCI with propofol in ophthalmic ambulatory surgery, so that to evaluate a better anesthesia method in ophthalmic surgery through a large sample clinical study.

Conditions

Ophthalmic; Surgery; Anesthesia

Keywords

Ambulatory surgery; Ophthalmic; Inhalation anesthesia; Desflurane; Total intravenous anesthesia

Outcome Measures

Primary Outcomes (1)

• Awake time

  "Anesthesia ends" means stop infusing or inhaling any anaesthetic.

  From the ending time of anesthesia until the recovery time of patient's consciousness, assessed up to half an hour postoperatively.

Secondary Outcomes (7)

• Discharge time

  From the ending time of anesthesia until the time of extubation, assessed up to half an hour postoperatively.

• Stay time in the postoperative care unit

  Measuring the stay time in postoperative care unit, assessed up to one hour postoperatively.

• Quality of recovery in 1 day postoperatively

  Start scaling when 1 day(24 hour) postoperatively.

• Incidences in postoperative nausea and vomiting(PONV)

  Start scaling in 1 day(24 hour) postoperatively.

• Incidences in postoperative agitation

  Start scaling in 1 day(24 hour) postoperatively.

Study Arms (2)

Group TIVA

EXPERIMENTAL

method of anesthesia is total intravenous anesthesia(TIVA) and maintenance with propofol Cp 2-4 μg/ml and remifentanil 2-4 ng/ml in target controlled infusion(TCI) during the procedure

Procedure: total intravenous anesthesia; Drug: Propofol; Drug: Remifentanil

Group Des

EXPERIMENTAL

method of anesthesia is inhalation anesthesia and maintenance with desflurane ranged from 0.5\~1.5 MAC during the procedure

Drug: desflurane; Procedure: inhalation anesthesia

Interventions

desflurane DRUG

method of anesthesia maintenance with desflurane ranged from 0.5\~1.5 MAC during the procedure

Also known as: Ethane,2--1,1,1,2-tetrafluoro

Group Des

total intravenous anesthesia PROCEDURE

method of anesthesia in group TIVA is total intravenous anesthesia(TIVA) during the procedure

Also known as: TIVA

Group TIVA

inhalation anesthesia PROCEDURE

method of anesthesia in group DES is inhalation anesthesia with desflurane during the procedure

Group Des

Propofol DRUG

using propofol as sedative during the procedure of anesthesia and maintaining with propofol Cp 2-4 μg/ml in TCI

Also known as: Disoprofol

Group TIVA

Remifentanil DRUG

using remifentanil as analgesics during the procedure of anesthesia and maintaining with remifentanil 2-4 ng/ml in TCI

Also known as: Remifentanil Hydrochloride for Injection

Group TIVA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years patients undergoing selective ophthalmic ambulatory surgery；
• ASA I and II
• duration of anesthesia at least 30min
• without apparent organ comorbidities
• sign the informed consent form

You may not qualify if:

• equal or greater than ASA III
• has a history of dementia，psychiatric disorders or central nervous system diseases
• taking sedatives, antidepressant or glucocorticoid
• without family members
• has cardiac, respiratory，liver，kidney comorbidities
• uncontrolled hypertension（\>180/100mmHg）
• laryngeal mask fail to insert, and change to tracheal intubation

Sponsors & Collaborators

• Xiaoliang Gan: lead

Study Sites (1)

Zhongshan ophthalmic center, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (10)

• Aylin P, Williams S, Jarman B, Bottle A. Trends in day surgery rates. BMJ. 2005 Oct 8;331(7520):803. doi: 10.1136/bmj.331.7520.803. No abstract available.

  PMID: 16210281 BACKGROUND

• Neel ST. Effect of Conversion to Immediate Sequential Cataract Surgery on Ambulatory Surgery Centers in the United States in the Cost-Analysis Model. JAMA Ophthalmol. 2015 Jul;133(7):856-7. doi: 10.1001/jamaophthalmol.2015.0941. No abstract available.

  PMID: 25906175 BACKGROUND

• Chen CH, Yang YL, Chen WM, Shyr MH. Comparison of the anesthesia profiles between sevoflurane-nitrous oxide and propofol-nitrous oxide conveyed by laryngeal mask airway in patients undergoing ambulatory gynecological surgery. Acta Anaesthesiol Taiwan. 2006 Jun;44(2):101-7.

  PMID: 16845915 BACKGROUND

• Kumar G, Stendall C, Mistry R, Gurusamy K, Walker D. A comparison of total intravenous anaesthesia using propofol with sevoflurane or desflurane in ambulatory surgery: systematic review and meta-analysis. Anaesthesia. 2014 Oct;69(10):1138-50. doi: 10.1111/anae.12713. Epub 2014 May 22.

  PMID: 24847783 BACKGROUND

• Coskun D, Celebi H, Karaca G, Karabiyik L. Remifentanil versus fentanyl compared in a target-controlled infusion of propofol anesthesia: quality of anesthesia and recovery profile. J Anesth. 2010 Jun;24(3):373-9. doi: 10.1007/s00540-010-0898-1. Epub 2010 Mar 13.

  PMID: 20229001 BACKGROUND

• Majholm B, Bartholdy J, Clausen HV, Virkus RA, Engbaek J, Moller AM. Comparison between local anaesthesia with remifentanil and total intravenous anaesthesia for operative hysteroscopic procedures in day surgery. Br J Anaesth. 2012 Feb;108(2):245-53. doi: 10.1093/bja/aer337. Epub 2011 Nov 23.

  PMID: 22113931 BACKGROUND

• Eikaas H, Raeder J. Total intravenous anaesthesia techniques for ambulatory surgery. Curr Opin Anaesthesiol. 2009 Dec;22(6):725-9. doi: 10.1097/ACO.0b013e3283310f6b.

  PMID: 19680121 BACKGROUND

• Yoo YC, Bai SJ, Lee KY, Shin S, Choi EK, Lee JW. Total intravenous anesthesia with propofol reduces postoperative nausea and vomiting in patients undergoing robot-assisted laparoscopic radical prostatectomy: a prospective randomized trial. Yonsei Med J. 2012 Nov 1;53(6):1197-202. doi: 10.3349/ymj.2012.53.6.1197.

  PMID: 23074122 BACKGROUND

• Rinehardt EK, Sivarajan M. Costs and wastes in anesthesia care. Curr Opin Anaesthesiol. 2012 Apr;25(2):221-5. doi: 10.1097/ACO.0b013e32834f00ec.

  PMID: 22157199 BACKGROUND

• Zhu YL, Shen WH, Chen QR, Ye HJ, Huang JX, Kang Y, Chi W, Gan XL. Desflurane anesthesia compared with total intravenous anesthesia on anesthesia-controlled operating room time in ambulatory surgery following strabotomy: a randomized controlled study. Chin Med J (Engl). 2020 Apr 5;133(7):779-785. doi: 10.1097/CM9.0000000000000728.

  PMID: 32149764 DERIVED

MeSH Terms

Interventions

Desflurane; Anesthesia, Inhalation; Propofol; Remifentanil; Injections

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Anesthesia, General; Anesthesia; Anesthesia and Analgesia; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yizhi Liu

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 4, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

CN (1)