Comparison of Desflurane Anesthesia Versus TIVA-TCI in Patients Undergoing Ophthalmic Ambulatory Surgery
Keywords
Abstract
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.
Dates
| Last Verified: | 12/31/2017 |
| First Submitted: | 09/27/2016 |
| Estimated Enrollment Submitted: | 09/29/2016 |
| First Posted: | 10/03/2016 |
| Last Update Submitted: | 01/20/2018 |
| Last Update Posted: | 01/22/2018 |
| Actual Study Start Date: | 09/30/2016 |
| Estimated Primary Completion Date: | 11/30/2017 |
| Estimated Study Completion Date: | 12/31/2017 |
Condition or disease
Intervention/treatment
Drug: Group Des
Procedure: Group TIVA
Procedure: Group Des
Drug: Group TIVA
Drug: Group TIVA
Phase
Arm Groups
| 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: Group TIVA method of anesthesia in group TIVA is total intravenous anesthesia(TIVA) during the procedure |
| Experimental: Group Des method of anesthesia is inhalation anesthesia and maintenance with desflurane ranged from 0.5~1.5 MAC during the procedure | Drug: Group Des method of anesthesia maintenance with desflurane ranged from 0.5~1.5 MAC during the procedure |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Awake time [From the ending time of anesthesia until the recovery time of patient's consciousness, assessed up to half an hour postoperatively.]
Secondary Outcome Measures
1. Discharge time [From the ending time of anesthesia until the time of extubation, assessed up to half an hour postoperatively.]
2. Stay time in the postoperative care unit [Measuring the stay time in postoperative care unit, assessed up to one hour postoperatively.]
3. Quality of recovery in 1 day postoperatively [Start scaling when 1 day(24 hour) postoperatively.]
4. Incidences in postoperative nausea and vomiting(PONV) [Start scaling in 1 day(24 hour) postoperatively.]
5. Incidences in postoperative agitation [Start scaling in 1 day(24 hour) postoperatively.]
6. Anesthesia cost [During the procedure of anesthesia.]
7. Postoperative VAS pain score [Start scaling in half an hour postoperatively when patient's consciousness returns.]
