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

NCT ID: NCT02922660

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-01-31

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.

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.

Conditions

Ophthalmic; Surgery; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

total intravenous anesthesia

Intervention Type: PROCEDURE

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

Propofol

Intervention Type: DRUG

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

Remifentanil

Intervention Type: DRUG

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

Group Des

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

Group Type: EXPERIMENTAL

desflurane

Intervention Type: DRUG

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

inhalation anesthesia

Intervention Type: PROCEDURE

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

Interventions

desflurane

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

Intervention Type: DRUG

total intravenous anesthesia

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

Intervention Type: PROCEDURE

inhalation anesthesia

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

Intervention Type: PROCEDURE

Propofol

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

Intervention Type: DRUG

Remifentanil

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

Intervention Type: DRUG

Other Intervention Names

Ethane,2--1,1,1,2-tetrafluoro; TIVA; Disoprofol; Remifentanil Hydrochloride for Injection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xiaoliang Gan

OTHER

Sponsor Role: lead

Responsible Party

Xiaoliang Gan

associate chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yizhi Liu

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan ophthalmic center, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

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Reference Type: DERIVED

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Other Identifiers

ZOCMZK-2016

Identifier Type: -

Identifier Source: org_study_id