NCT04712162

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

January 12, 2021

Last Update Submit

January 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to awakening

    Time required for awakening

    After stopping volatile anesthetics to patient awakening, up to 30 minutes.

Secondary Outcomes (4)

  • Time to wash-out of volatile anesthetics

    After stopping volatile anesthetics to complete wash-out of volatile anesthetics, up to 30 minutes

  • Time to extubation

    After stopping volatile anesthetics to readiness for extubation, up to 30 minutes

  • Irritation after awakening

    After awakening to eligible discharge, up to 2 hours.

  • Adverse effects of volatile anesthetics

    After providing volatile anesthetics until they were stopped, up to 90 minutes

Study Arms (2)

D: maintain anesthesia with desflurane

OTHER

D: maintain anesthesia with Suprane® (Desflurane) at 6%. Volatile concentration was titrated according to end-tidal MAC to maintain 0.7-1.3 MAC using end-tidal monitor of Dräger Primus anesthesia machine.

Other: Other

S: maintain anesthesia with sevoflurane.

OTHER

S: maintain anesthesia with Sevorane® (Sevoflurane) at 2%. Volatile concentration was titrated according to end-tidal MAC to maintain 0.7-1.3 MAC using end-tidal monitor of Dräger Primus anesthesia machine.

Other: Other

Interventions

OtherOTHER

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

D: maintain anesthesia with desfluraneS: maintain anesthesia with sevoflurane.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All eligible subjects who underwent endoscopic ureteral lithotripsy under general anesthesia
  • ASA I and II

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology Department of Gia Dinh People Hospital

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (21)

  • 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. doi: 10.1023/A:1012216600170.

    PMID: 12580235BACKGROUND
  • 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. doi: 10.1097/00000542-200207000-00012.

    PMID: 12131107BACKGROUND
  • Eger EI 2nd, Saidman LJ, Brandstater B. Minimum alveolar anesthetic concentration: a standard of anesthetic potency. Anesthesiology. 1965 Nov-Dec;26(6):756-63. doi: 10.1097/00000542-196511000-00010. No abstract available.

    PMID: 5844267BACKGROUND
  • 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. doi: 10.1097/00000542-199801000-00006.

    PMID: 9447851BACKGROUND
  • 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. doi: 10.1097/00000542-199902000-00012.

    PMID: 9952144BACKGROUND
  • 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. doi: 10.1097/00000542-199103000-00007.

    PMID: 2001020BACKGROUND
  • 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.

    PMID: 22037642BACKGROUND
  • Aldrete JA. Post-anesthetic recovery score. J Am Coll Surg. 2007 Nov;205(5):e3-4; author reply e4-5. doi: 10.1016/j.jamcollsurg.2007.07.034. No abstract available.

  • Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. No abstract available.

  • 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: 10.1111/aas.12435. Epub 2014 Nov 14.

  • 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 trial. J Clin Anesth. 2013 Dec;25(8):651-8. doi: 10.1016/j.jclinane.2013.07.006. Epub 2013 Oct 4.

  • 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.

  • 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. eCollection 2015 Feb.

  • 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.

  • 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. doi: 10.1093/bja/aem197. Epub 2007 Jul 9.

  • Mahmoud NA, Rose DJ, Laurence AS. Desflurane or sevoflurane for gynaecological day-case anaesthesia with spontaneous respiration? Anaesthesia. 2001 Feb;56(2):171-4. doi: 10.1046/j.1365-2044.2001.01528.x.

  • 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 2015 Oct 20.

  • 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):549-52. doi: 10.1111/j.1399-6576.2006.001022.x.

  • 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. doi: 10.5455/medarh.2011.65.216-220.

  • 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. doi: 10.3389/fmed.2015.00075. eCollection 2015.

  • 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. doi: 10.1093/oxfordjournals.bja.a013467.

Study Officials

  • Thanh T. Nguyen, PhD

    Gia Dinh People Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 15, 2021

Study Start

November 19, 2019

Primary Completion

May 7, 2020

Study Completion

May 7, 2020

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE

Locations