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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ophthalmic, Surgery, Anesthesia

Intervention / Treatment
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* Drug: desflurane
* Procedure: total intravenous anesthesia
* Procedure: inhalation anesthesia
* Drug: Propofol
* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group TIVA<br>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<br>* method of anesthesia in group TIVA is total intravenous anesthesia(TIVA) during the procedure<br>* Other names: TIVA;Drug: Propofol<br>* using propofol as sedative during the procedure of anesthesia and maintaining with propofol Cp 2-4 μg/ml in TCI<br>* Other names: Disoprofol;Drug: Remifentanil<br>* using remifentanil as analgesics during the procedure of anesthesia and maintaining with remifentanil 2-4 ng/ml in TCI<br>* Other names: Remifentanil Hydrochloride for Injection;|
| Experimental: Group Des<br>method of anesthesia is inhalation anesthesia and maintenance with desflurane ranged from 0.5 1.5 MAC during the procedure | Drug: desflurane<br>* method of anesthesia maintenance with desflurane ranged from 0.5 1.5 MAC during the procedure<br>* Other names: Ethane,2--1,1,1,2-tetrafluoro;Procedure: inhalation anesthesia<br>* method of anesthesia in group DES is inhalation anesthesia with desflurane during the procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Awake time | Anesthesia ends means stop infusing or inhaling any anaesthetic. | From the ending time of anesthesia until the recovery time of patient's consciousness, assessed up to half an hour postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 |  | 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. | Start scaling when 1 day(24 hour) postoperatively. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ambulatory surgery, Ophthalmic, Inhalation anesthesia, Desflurane, Total intravenous anesthesia