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

Xiaoliang Gan209 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

209

Conditions

Ophthalmic Surgery Anesthesia

Interventions

desfluraneDRUG

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

total intravenous anesthesiaPROCEDURE

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

inhalation anesthesiaPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Zhongshan ophthalmic center, Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Awake time

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

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

Secondary Outcomes

Discharge time

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.

Time frame: 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.

Quality of recovery in 1 day postoperatively

It will use telephone follow-up for the patients enrolled.

Time frame: 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.

Incidences in postoperative agitation

Time frame: Start scaling in 1 day(24 hour) postoperatively.

Anesthesia cost

Time frame: During the procedure of anesthesia.

Postoperative VAS pain score

Time frame: Start scaling in half an hour postoperatively when patient's consciousness returns.

Data from ClinicalTrials.gov

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