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

Not Applicable

Completed

• Conditions: Anesthesia; Ophthalmic; Surgery
• Interventions: Procedure: total intravenous anesthesia; Drug: desflurane; Drug: Propofol; Procedure: inhalation anesthesia; Drug: Remifentanil

• Registration Number: NCT02922660
• Lead Sponsor: Xiaoliang Gan

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.

Study Timeline

• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-09-30
• Study Start: 2016-10
• Study First Posted: 2016-10-04
• Primary Completion: 2017-12
• Status Verified: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-01-21
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group TIVA	total intravenous anesthesia	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 TIVA	Propofol	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 Des	inhalation anesthesia	method of anesthesia is inhalation anesthesia and maintenance with desflurane ranged from 0.5\~1.5 MAC during the procedure
Group TIVA	Remifentanil	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 Des	desflurane	method of anesthesia is inhalation anesthesia and maintenance with desflurane ranged from 0.5\~1.5 MAC during the procedure

Primary Outcome Measures

Name	Time	Method
Awake time	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative VAS pain score	Start scaling in half an hour postoperatively when patient's consciousness returns.
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.	It will use telephone follow-up for the patients enrolled.
Discharge time	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.
Incidences in postoperative nausea and vomiting(PONV)	Start scaling in 1 day(24 hour) postoperatively.
Anesthesia cost	During the procedure of anesthesia.
Incidences in postoperative agitation	Start scaling in 1 day(24 hour) postoperatively.

Trial Locations

Locations (1)

Zhongshan ophthalmic center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China