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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group TIVA | Experimental | 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 | Experimental | method of anesthesia is inhalation anesthesia and maintenance with desflurane ranged from 0.5~1.5 MAC during the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| desflurane | Drug | method of anesthesia maintenance with desflurane ranged from 0.5~1.5 MAC during the procedure |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yizhi Liu | Zhongshan Ophthalmic Center, Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan ophthalmic center, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16210281 | Background | Aylin P, Williams S, Jarman B, Bottle A. Trends in day surgery rates. BMJ. 2005 Oct 8;331(7520):803. doi: 10.1136/bmj.331.7520.803. No abstract available. | |
| 25906175 | Background | Neel ST. Effect of Conversion to Immediate Sequential Cataract Surgery on Ambulatory Surgery Centers in the United States in the Cost-Analysis Model. JAMA Ophthalmol. 2015 Jul;133(7):856-7. doi: 10.1001/jamaophthalmol.2015.0941. No abstract available. |
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| ID | Term |
|---|---|
| D000077335 | Desflurane |
| D000769 | Anesthesia, Inhalation |
| D015742 | Propofol |
| D000077208 | Remifentanil |
| D007267 | Injections |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
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| total intravenous anesthesia | Procedure | method of anesthesia in group TIVA is total intravenous anesthesia(TIVA) during the procedure |
|
|
| inhalation anesthesia | Procedure | method of anesthesia in group DES is inhalation anesthesia with desflurane during the procedure |
|
| Propofol | Drug | using propofol as sedative during the procedure of anesthesia and maintaining with propofol Cp 2-4 μg/ml in TCI |
|
|
| Remifentanil | Drug | using remifentanil as analgesics during the procedure of anesthesia and maintaining with remifentanil 2-4 ng/ml in TCI |
|
|
| 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. |
| 16845915 | Background | Chen CH, Yang YL, Chen WM, Shyr MH. Comparison of the anesthesia profiles between sevoflurane-nitrous oxide and propofol-nitrous oxide conveyed by laryngeal mask airway in patients undergoing ambulatory gynecological surgery. Acta Anaesthesiol Taiwan. 2006 Jun;44(2):101-7. |
| 24847783 | Background | Kumar G, Stendall C, Mistry R, Gurusamy K, Walker D. A comparison of total intravenous anaesthesia using propofol with sevoflurane or desflurane in ambulatory surgery: systematic review and meta-analysis. Anaesthesia. 2014 Oct;69(10):1138-50. doi: 10.1111/anae.12713. Epub 2014 May 22. |
| 20229001 | Background | Coskun D, Celebi H, Karaca G, Karabiyik L. Remifentanil versus fentanyl compared in a target-controlled infusion of propofol anesthesia: quality of anesthesia and recovery profile. J Anesth. 2010 Jun;24(3):373-9. doi: 10.1007/s00540-010-0898-1. Epub 2010 Mar 13. |
| 22113931 | Background | Majholm B, Bartholdy J, Clausen HV, Virkus RA, Engbaek J, Moller AM. Comparison between local anaesthesia with remifentanil and total intravenous anaesthesia for operative hysteroscopic procedures in day surgery. Br J Anaesth. 2012 Feb;108(2):245-53. doi: 10.1093/bja/aer337. Epub 2011 Nov 23. |
| 19680121 | Background | Eikaas H, Raeder J. Total intravenous anaesthesia techniques for ambulatory surgery. Curr Opin Anaesthesiol. 2009 Dec;22(6):725-9. doi: 10.1097/ACO.0b013e3283310f6b. |
| 23074122 | Background | Yoo YC, Bai SJ, Lee KY, Shin S, Choi EK, Lee JW. Total intravenous anesthesia with propofol reduces postoperative nausea and vomiting in patients undergoing robot-assisted laparoscopic radical prostatectomy: a prospective randomized trial. Yonsei Med J. 2012 Nov 1;53(6):1197-202. doi: 10.3349/ymj.2012.53.6.1197. |
| 22157199 | Background | Rinehardt EK, Sivarajan M. Costs and wastes in anesthesia care. Curr Opin Anaesthesiol. 2012 Apr;25(2):221-5. doi: 10.1097/ACO.0b013e32834f00ec. |
| 32149764 | Derived | Zhu YL, Shen WH, Chen QR, Ye HJ, Huang JX, Kang Y, Chi W, Gan XL. Desflurane anesthesia compared with total intravenous anesthesia on anesthesia-controlled operating room time in ambulatory surgery following strabotomy: a randomized controlled study. Chin Med J (Engl). 2020 Apr 5;133(7):779-785. doi: 10.1097/CM9.0000000000000728. |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D000768 | Anesthesia, General |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |