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

Xiaoliang Gan

Status

Completed

Conditions

Surgery

Ophthalmic

Anesthesia

Treatments

Drug: Propofol

Drug: desflurane

Drug: Remifentanil

Procedure: total intravenous anesthesia

Procedure: inhalation anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT02922660

ZOCMZK-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment

209 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

209 participants in 2 patient groups

Group TIVA

Experimental group

Description:

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

Treatment: