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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922660
• Other study ID #: ZOCMZK-2016
• Status: Completed
• Phase: N/A
• First received: September 28, 2016
• Last updated: January 21, 2018
• Start date: October 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Ophthalmic
• Surgery

Intervention

Drug:
• desflurane
method of anesthesia maintenance with desflurane ranged from 0.5~1.5 MAC during the procedure

Procedure:
• total intravenous anesthesia
method of anesthesia in group TIVA is total intravenous anesthesia(TIVA) during the procedure
• inhalation anesthesia
method of anesthesia in group DES is inhalation anesthesia with desflurane during the procedure

Drug:
• Propofol
using propofol as sedative during the procedure of anesthesia and maintaining with propofol Cp 2—4 µg/ml in TCI
• Remifentanil
using remifentanil as analgesics during the procedure of anesthesia and maintaining with remifentanil 2—4 ng/ml in TCI

Locations

Country	Name	City	State
China	Zhongshan ophthalmic center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoliang Gan

Country where clinical trial is conducted

China, 

References & Publications (9)

Aylin P, Williams S, Jarman B, Bottle A. Trends in day surgery rates. BMJ. 2005 Oct 8;331(7520):803. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Majholm B, Bartholdy J, Clausen HV, Virkus RA, Engbæk J, Møller 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. — View Citation

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. — View Citation

Rinehardt EK, Sivarajan M. Costs and wastes in anesthesia care. Curr Opin Anaesthesiol. 2012 Apr;25(2):221-5. doi: 10.1097/ACO.0b013e32834f00ec. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Stay time in the postoperative care unit		Measuring the stay time in postoperative care unit, assessed up to one hour postoperatively.
Secondary	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.
Secondary	Incidences in postoperative nausea and vomiting(PONV)		Start scaling in 1 day(24 hour) postoperatively.
Secondary	Incidences in postoperative agitation		Start scaling in 1 day(24 hour) postoperatively.
Secondary	Anesthesia cost		During the procedure of anesthesia.
Secondary	Postoperative VAS pain score		Start scaling in half an hour postoperatively when patient's consciousness returns.