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AnesthesiaNCT04712162

The Quality of Recovery After General Anesthesia With Desflurane and Sevoflurane in Endoscopic Ureteral Lithotripsy

A study testing Other in people with Anesthesia, run by Gia Dinh People Hospital at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Anesthesia
What is being tested?
Other
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteVietnam
Study dates
19 Nov 2019to 7 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Anesthesiology Department of Gia Dinh People Hospital

    Ho Chi Minh City, 700000

Other trials in Vietnam

About this study

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.

Read the detailed 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

Conditions
Anesthesia
Being tested
Other

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OtherOther

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

Study groups in NCT04712162
Study groupRoleWhat they receive
D: maintain anesthesia with desfluraneOtherD: 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.
Receives: Other: Other
S: maintain anesthesia with sevoflurane.OtherS: 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.
Receives: Other: Other

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to awakening

    Time required for awakening

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

Secondary outcomes (4)

  1. Time to wash-out of volatile anesthetics

    Time required for washing out volatile anesthetics

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

  2. Time to extubation

    Time required for successful extubation.

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

  3. Irritation after awakening

    Aono score >2

    Measured: After awakening to eligible discharge, up to 2 hours.

  4. Adverse effects of volatile anesthetics

    Hypotension, cough, nausea and vomitting.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start19 Nov 2019
  3. Primary completion7 May 2020
  4. Study completion7 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04712162
Sponsor's protocol ID
81/CN-HĐĐĐ
Status last verified
Jan 2021
First submitted
12 Jan 2021
Last updated
15 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 12580235

  • 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.

    PubMed 12131107

  • 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.

    PubMed 5844267

  • 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.

    PubMed 9447851

  • 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.

    PubMed 9952144

  • 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.

    PubMed 2001020

  • 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.

    PubMed 22037642

  • 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.

    PubMed 17964430

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

    PubMed 5534693

  • 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.

    PubMed 25395384

  • 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.

    PubMed 24095885

  • 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.

    PubMed 24944378

  • 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.

    PubMed 25789236

  • 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.

    PubMed 23493107

  • 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.

    PubMed 17621601

Questions about this trial

What is this clinical trial studying?

A study testing Other in people with Anesthesia, run by Gia Dinh People Hospital at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to awakening (time frame: After stopping volatile anesthetics to patient awakening, up to 30 minutes.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04712162, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.

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