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

January 21, 2018 updated by: Xiaoliang Gan

Comparison of Desflurane Balanced Anesthesia Versus TIVA-TCI (Total IntraVenous Anesthesia-Target Controlled Infusion) in Patients Undergoing Ophthalmic Ambulatory Surgery: A Single Center, Prospective, Randomized, Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Desflurane balanced anesthesia and TIVA-TCI(Total IntraVenous Anesthesia-Target Controlled Infusion) are commonly used in ophthalmic ambulatory surgery, however, there is no clear evidence to discriminate the advantages and disadvantages between them. This study is designed to evaluate a better anesthetic method in ophthalmic surgery through a clinical study. This is a single center, randomized, prospective study. 200 patients with American Society of Anesthesiologists'(ASA) physical status 1 to 2, aged 18 to 60, scheduled for elective strabismus ambulatory and in whom a LMA is indicated for anesthesia are recruited. Enrolled patients are randomly assigned into 2 groups: group TIVA (TIVA-TCI with propofol) and group Des (Desflurane).In group TIVA, anesthesia is maintained with propofol and remifentanil. Propofol is continuously administered via a target-controlled infusion (TCI) pump intraoperatively. In group Des, anesthesia is maintained with desflurane.All patients received anaesthesia depth monitoring with bispectral index (BIS). The dose of anesthetic is adjusted to maintained the BIS value within 40 to 60. At the end of the surgery, inhalant anesthetic or infused propofol and remifentanil are discontinued. LMA is removed when patient regains consciousness with spontaneous respiration. Patients are then transferred to the post anesthetic care unit (PACU) for postoperative follow-up. The primary outcome is awake time, the secondary outcomes include discharge time, the stay time in PACU, time of off-bed, Riker sedation agitation score (SAS), time of PADSS>9, NRS score when leaving PACU, incidence of various complications (postoperative nausea and vomiting (PONV), emergence agitation, etc), as well as anesthesia cost. All patients are followed up by calling in one day after the surgery.

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-60 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group TIVA
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
method of anesthesia in group TIVA is total intravenous anesthesia(TIVA) during the procedure
Other Names:
  • TIVA
Drug: Propofol
using propofol as sedative during the procedure of anesthesia and maintaining with propofol Cp 2-4 μg/ml in TCI
Other Names:
  • Disoprofol
Drug: Remifentanil
using remifentanil as analgesics during the procedure of anesthesia and maintaining with remifentanil 2-4 ng/ml in TCI
Other Names:
  • Remifentanil Hydrochloride for Injection
Experimental: Group Des
method of anesthesia is inhalation anesthesia and maintenance with desflurane ranged from 0.5~1.5 MAC during the procedure
Drug: desflurane
method of anesthesia maintenance with desflurane ranged from 0.5~1.5 MAC during the procedure
Other Names:
  • Ethane,2--1,1,1,2-tetrafluoro
Procedure: inhalation anesthesia
method of anesthesia in group DES is inhalation anesthesia with desflurane during the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Awake time
Time Frame: From the ending time of anesthesia until the recovery time of patient's consciousness, assessed up to half an hour postoperatively.
"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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discharge time
Time Frame: From the ending time of anesthesia until the time of extubation, assessed up to half an hour postoperatively.
The standards of extubation are tidal volume(VT) 6～8 ml/kg，respiratory rate(RR) 10～12 times per minute，end-tidal carbon dioxide (ETCO2) 35～45 mmHg.
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
Time Frame: Measuring the stay time in postoperative care unit, assessed up to one hour postoperatively.
Measuring the stay time in postoperative care unit, assessed up to one hour postoperatively.
Quality of recovery in 1 day postoperatively
Time Frame: Start scaling when 1 day(24 hour) postoperatively.
It will use telephone follow-up for the patients enrolled.
Start scaling when 1 day(24 hour) postoperatively.
Incidences in postoperative nausea and vomiting(PONV)
Time Frame: Start scaling in 1 day(24 hour) postoperatively.
Start scaling in 1 day(24 hour) postoperatively.
Incidences in postoperative agitation
Time Frame: Start scaling in 1 day(24 hour) postoperatively.
Start scaling in 1 day(24 hour) postoperatively.
Anesthesia cost
Time Frame: During the procedure of anesthesia.
During the procedure of anesthesia.
Postoperative VAS pain score
Time Frame: Start scaling in half an hour postoperatively when patient's consciousness returns.
Start scaling in half an hour postoperatively when patient's consciousness returns.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaoliang Gan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 21, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZOCMZK-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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