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

Sponsor

Xiaoliang Gan (Other)

Overall Status

Completed

CT.gov ID

NCT02922660

Collaborator

(none)

209

Enrollment

Location

Arms

Actual Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ophthalmic Surgery Anesthesia	Drug: desflurane Procedure: total intravenous anesthesia Procedure: inhalation anesthesia Drug: Propofol Drug: Remifentanil	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

209 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Jan 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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.
Incidences in postoperative nausea and vomiting(PONV) [Start scaling in 1 day(24 hour) postoperatively.]
Incidences in postoperative agitation [Start scaling in 1 day(24 hour) postoperatively.]
Anesthesia cost [During the procedure of anesthesia.]
Postoperative VAS pain score [Start scaling in half an hour postoperatively when patient's consciousness returns.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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