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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04712162
Other study ID # 81/CN-HÐÐÐ
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 19, 2019
Est. completion date May 7, 2020

Study information

Verified date January 2021
Source Gia Dinh People Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The good quality of recovery after general anesthesia is one of goals for short procedures and ambulatory surgeries. The study's objective was to compare the quality of recovery after general anesthesia with desflurane and sevoflurane with laryngeal mask airway for endoscopic ureteral lithotripsy.


Description:

This is a randomized controlled trial. There were 60 cases of endoscopic ureteral lithotripsy under general anesthesia with laryngeal mask airway were enrolled. All cases were randomly divided into two group (desflurane or sevoflurane). Each group had 30 cases. Primary outcome was time to awakening. Secondary outcomes were time to wash-out of volatile anesthetics, time to extubation, irritation after awakening, and modified Aldrete score. Statistical analysis was performed by using Kaplan-Meieir curve and log-rank test for time to adequate depth of anesthesia and time to awakening; t-test for time to wash-out of volatile anesthetics; chi-square test for depth of anesthesia by PRST score, irritation after awakening and Aldrete score; Fisher test for adverse effects of volatile anesthetics. The research was approved by Gia Dinh People Hospital ethics committee


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 7, 2020
Est. primary completion date May 7, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - All eligible subjects who underwent endoscopic ureteral lithotripsy under general anesthesia - ASA I and II Exclusion Criteria: - Contraindication to laryngeal mask airway. - Indication for conversion to tracheal intubation during surgery. - History of malignant hyperthermia. - Pregnancy. - Obese (BMI >25 kg/m2). - Substances abuse.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Other
Compare time to awakening and quality of recovery after general anesthesia between two groups.

Locations

Country Name City State
Vietnam Anesthesiology Department of Gia Dinh People Hospital Ho Chi Minh City

Sponsors (1)

Lead Sponsor Collaborator
Gia Dinh People Hospital

Country where clinical trial is conducted

Vietnam, 

References & Publications (21)

Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. — View Citation

Aldrete JA. Post-anesthetic recovery score. J Am Coll Surg. 2007 Nov;205(5):e3-4; author reply e4-5. — View Citation

Bruhn J, Bouillon TW, Shafer SL. Bispectral index (BIS) and burst suppression: revealing a part of the BIS algorithm. J Clin Monit Comput. 2000;16(8):593-6. — View Citation

Choi GJ, Baek CW, Kang H, Park YH, Yang SY, Shin HY, Jung YH, Woo YC, Lee UL. Emergence agitation after orthognathic surgery: a randomised controlled comparison between sevoflurane and desflurane. Acta Anaesthesiol Scand. 2015 Feb;59(2):224-31. doi: 10.11 — View Citation

De Oliveira GS Jr, Fitzgerald PC, Ahmad S, Marcus RJ, McCarthy RJ. Desflurane/fentanyl compared with sevoflurane/fentanyl on awakening and quality of recovery in outpatient surgery using a laryngeal mask airway: a randomized, double-blinded controlled tri — View Citation

Dogru K, Yildiz K, Madenoglu H, Boyaci A. Early recovery properties of sevoflurane and desflurane in patients undergoing total hip replacement surgery. Curr Ther Res Clin Exp. 2003 May;64(5):301-9. doi: 10.1016/S0011-393X(03)00086-9. — View Citation

Drover DR, Lemmens HJ, Pierce ET, Plourde G, Loyd G, Ornstein E, Prichep LS, Chabot RJ, Gugino L. Patient State Index: titration of delivery and recovery from propofol, alfentanil, and nitrous oxide anesthesia. Anesthesiology. 2002 Jul;97(1):82-9. — View Citation

Eger EI 2nd, Saidman LJ, Brandstater B. Minimum alveolar anesthetic concentration: a standard of anesthetic potency. Anesthesiology. 1965 Nov-Dec;26(6):756-63. — View Citation

Green MS, Green P, Neubert L, Voralu K, Saththasivam P, Mychaskiw G. Recovery following desflurane versus sevoflurane anesthesia for outpatient urologic surgery in elderly females. Anesth Pain Med. 2015 Feb 1;5(1):e22271. doi: 10.5812/aapm.22271. eCollect — View Citation

Katoh T, Ikeda K. The effects of fentanyl on sevoflurane requirements for loss of consciousness and skin incision. Anesthesiology. 1998 Jan;88(1):18-24. — View Citation

Katoh T, Kobayashi S, Suzuki A, Iwamoto T, Bito H, Ikeda K. The effect of fentanyl on sevoflurane requirements for somatic and sympathetic responses to surgical incision. Anesthesiology. 1999 Feb;90(2):398-405. — View Citation

Kaur A, Jain AK, Sehgal R, Sood J. Hemodynamics and early recovery characteristics of desflurane versus sevoflurane in bariatric surgery. J Anaesthesiol Clin Pharmacol. 2013 Jan;29(1):36-40. doi: 10.4103/0970-9185.105792. — View Citation

La Colla L, Albertin A, La Colla G, Mangano A. Faster wash-out and recovery for desflurane vs sevoflurane in morbidly obese patients when no premedication is used. Br J Anaesth. 2007 Sep;99(3):353-8. Epub 2007 Jul 9. — View Citation

Mahmoud NA, Rose DJ, Laurence AS. Desflurane or sevoflurane for gynaecological day-case anaesthesia with spontaneous respiration? Anaesthesia. 2001 Feb;56(2):171-4. — View Citation

Mikuni I, Harada S, Yakushiji R, Iwasaki H. Effects of changing from sevoflurane to desflurane on the recovery profile after sevoflurane induction: a randomized controlled study. Can J Anaesth. 2016 Mar;63(3):290-7. doi: 10.1007/s12630-015-0514-9. Epub 20 — View Citation

Rampil IJ, Lockhart SH, Zwass MS, Peterson N, Yasuda N, Eger EI 2nd, Weiskopf RB, Damask MC. Clinical characteristics of desflurane in surgical patients: minimum alveolar concentration. Anesthesiology. 1991 Mar;74(3):429-33. — View Citation

Saros GB, Doolke A, Anderson RE, Jakobsson JG. Desflurane vs. sevoflurane as the main inhaled anaesthetic for spontaneous breathing via a laryngeal mask for varicose vein day surgery: a prospective randomized study. Acta Anaesthesiol Scand. 2006 May;50(5) — View Citation

Smajic J, Praso M, Hodzic M, Hodzic S, Srabovic-Okanovic A, Smajic N, Djonlagic Z. Assessment of depth of anesthesia: PRST score versus bispectral index. Med Arh. 2011;65(4):216-20. — View Citation

Werner JG, Castellon-Larios K, Thongrong C, Knudsen BE, Lowery DS, Antor MA, Bergese SD. Desflurane Allows for a Faster Emergence When Compared to Sevoflurane without Affecting the Baseline Cognitive Recovery Time. Front Med (Lausanne). 2015 Oct 28;2:75. — View Citation

Whitlock EL, Villafranca AJ, Lin N, Palanca BJ, Jacobsohn E, Finkel KJ, Zhang L, Burnside BA, Kaiser HA, Evers AS, Avidan MS. Relationship between bispectral index values and volatile anesthetic concentrations during the maintenance phase of anesthesia in the B-Unaware trial. Anesthesiology. 2011 Dec;115(6):1209-18. doi: 10.1097/ALN.0b013e3182395dcb. — View Citation

Wissing H, Kuhn I, Rietbrock S, Fuhr U. Pharmacokinetics of inhaled anaesthetics in a clinical setting: comparison of desflurane, isoflurane and sevoflurane. Br J Anaesth. 2000 Apr;84(4):443-9. — View Citation

* Note: There are 21 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Time to awakening Time required for awakening After stopping volatile anesthetics to patient awakening, up to 30 minutes.
Secondary Time to wash-out of volatile anesthetics Time required for washing out volatile anesthetics After stopping volatile anesthetics to complete wash-out of volatile anesthetics, up to 30 minutes
Secondary Time to extubation Time required for successful extubation. After stopping volatile anesthetics to readiness for extubation, up to 30 minutes
Secondary Irritation after awakening Aono score >2 After awakening to eligible discharge, up to 2 hours.
Secondary Adverse effects of volatile anesthetics Hypotension, cough, nausea and vomitting. After providing volatile anesthetics until they were stopped, up to 90 minutes
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