Zhongshan ophthalmic center, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
NCT Number: NCT02922660
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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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510080, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
method of anesthesia in group TIVA is total intravenous anesthesia(TIVA) during the procedure
Other names: TIVA
method of anesthesia in group DES is inhalation anesthesia with desflurane during the procedure
using propofol as sedative during the procedure of anesthesia and maintaining with propofol Cp 2-4 μg/ml in TCI
Other names: Disoprofol
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
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.
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.
Time frame: Measuring the stay time in postoperative care unit, assessed up to one hour postoperatively.
Time frame: Start scaling when 1 day(24 hour) postoperatively.
It will use telephone follow-up for the patients enrolled.
Time frame: Start scaling in 1 day(24 hour) postoperatively.
Time frame: Start scaling in 1 day(24 hour) postoperatively.
Time frame: During the procedure of anesthesia.
Time frame: Start scaling in half an hour postoperatively when patient's consciousness returns.
Xiaoliang Gan
Other
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
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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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