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OphthalmicNCT02922660

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

A study testing desflurane, total intravenous anesthesia and inhalation anesthesia in people with Ophthalmic and Surgery, run by Xiaoliang Gan at 1 site in China.

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

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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Ophthalmic, Surgery, Anesthesia
What is being tested?
desflurane, total intravenous anesthesia and inhalation anesthesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
209 participants
Where
1 siteChina
Study dates
Oct 2016to Jan 2018
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan ophthalmic center, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

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

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.

Read the detailed 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.

Being tested
desflurane, total intravenous anesthesia, inhalation anesthesia, Propofol, Remifentanil
Keywords
Ambulatory surgery, Ophthalmic, Inhalation anesthesia, Desflurane, Total intravenous anesthesia

What participants receive

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

  • desfluraneDrug

    Also called Ethane,2--1,1,1,2-tetrafluoro

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

  • total intravenous anesthesiaProcedure or surgery

    Also called TIVA

    method of anesthesia in group TIVA is total intravenous anesthesia(TIVA) during the procedure

  • inhalation anesthesiaProcedure or surgery

    method of anesthesia in group DES is inhalation anesthesia with desflurane during the procedure

  • PropofolDrug

    Also called Disoprofol

    using propofol as sedative during the procedure of anesthesia and maintaining with propofol Cp 2-4 μg/ml in TCI

  • RemifentanilDrug

    Also called Remifentanil Hydrochloride for Injection

    using remifentanil as analgesics during the procedure of anesthesia and maintaining with remifentanil 2-4 ng/ml in TCI

Study groups in NCT02922660
Study groupRoleWhat they receive
Group TIVAExperimentalmethod 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
Receives: Procedure: total intravenous anesthesia; Drug: Propofol; Drug: Remifentanil
Group DesExperimentalmethod of anesthesia is inhalation anesthesia and maintenance with desflurane ranged from 0.5~1.5 MAC during the procedure
Receives: Drug: desflurane; Procedure: inhalation anesthesia

What is being measured

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

  1. Awake time

    "Anesthesia ends" means stop infusing or inhaling any anaesthetic.

    Measured: From the ending time of anesthesia until the recovery time of patient's consciousness, assessed up to half an hour postoperatively.

Secondary outcomes (7)

  1. 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.

    Measured: From the ending time of anesthesia until the time of extubation, assessed up to half an hour postoperatively.

  2. Stay time in the postoperative care unit

    Measured: Measuring the stay time in postoperative care unit, assessed up to one hour postoperatively.

  3. Quality of recovery in 1 day postoperatively

    It will use telephone follow-up for the patients enrolled.

    Measured: Start scaling when 1 day(24 hour) postoperatively.

  4. Incidences in postoperative nausea and vomiting(PONV)

    Measured: Start scaling in 1 day(24 hour) postoperatively.

  5. Incidences in postoperative agitation

    Measured: Start scaling in 1 day(24 hour) postoperatively.

  6. Anesthesia cost

    Measured: During the procedure of anesthesia.

  7. Postoperative VAS pain score

    Measured: Start scaling in half an hour postoperatively when patient's consciousness returns.

Timeline

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

  1. First posted4 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionDec 2017
  4. Study completionJan 2018

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02922660
Sponsor's protocol ID
ZOCMZK-2016
Status last verified
Jan 2018
First submitted
28 Sep 2016
Last updated
23 Jan 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 16210281

  • 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.

    PubMed 25906175

  • 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.

    PubMed 16845915

  • 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.

    PubMed 24847783

  • 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.

    PubMed 20229001

  • 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.

    PubMed 22113931

  • 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.

    PubMed 19680121

  • 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.

    PubMed 23074122

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

    PubMed 22157199

  • 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.

    PubMed 32149764

Questions about this trial

What is this clinical trial studying?

A study testing desflurane, total intravenous anesthesia and inhalation anesthesia in people with Ophthalmic and Surgery, run by Xiaoliang Gan at 1 site in China.

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 5 inclusion and 7 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 23 Jan 2018. 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 China. 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?

Awake time (time frame: From the ending time of anesthesia until the recovery time of patient's consciousness, assessed up to half an hour postoperatively.). 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 NCT02922660, which also lists 10 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 23 Jan 2018.

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