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NCT Number: NCT02922660

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan ophthalmic center, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desflurane

Drug

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

Other names: Ethane,2--1,1,1,2-tetrafluoro

Total intravenous anesthesia

Procedure

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

Other names: TIVA

Inhalation anesthesia

Procedure

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

Propofol

Drug

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

Other names: Disoprofol

Remifentanil

Drug

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

Other names: Remifentanil Hydrochloride for Injection

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. Discharge time

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

    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.

  2. Stay time in the postoperative care unit

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

  3. Quality of recovery in 1 day postoperatively

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

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

  4. Incidences in postoperative nausea and vomiting(PONV)

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

  5. Incidences in postoperative agitation

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

  6. Anesthesia cost

    Time frame: During the procedure of anesthesia.

  7. Postoperative VAS pain score

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

Sponsors and collaborators

Lead sponsor

Xiaoliang Gan

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Oct 4, 2016
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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