An interventional study of Remimazolam and Sevoflurane in Emergence Agitation, Remimazolam and Sevoflurane, sponsored by Second Affiliated Hospital of Nanchang University. Completed at 1 site in China. Open to participants aged 3 Years to 8 Years. Per ClinicalTrials.gov, last updated 2023-03-24.
Sponsored by Second Affiliated Hospital of Nanchang University · Not applicable, Interventional, and Prevention
As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aims to investigate whether Remimazolam reduces the incidence of emergence agitation in children after ophthalmic surgery, compared to sevoflurane (RCT).
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 110 is above the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →Second Affiliated Hospital of Nanchang University is the lead sponsor of 78 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1. Induction of anesthesia Slowly inject Remimazolam 0.4-0.8 mg/kg (about 1 minute) until loss of consciousness (LoC), if the degree of sedation is insufficient, additional Remimazolam (0.05 mg/kg each time) is allowed. After the LoC, fentanyl 3-4 ug/kg and cisatracurium besilate 0.1 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope. 2. Maintenance of anesthesia Remimazolam 1\~2 mg/kg/h and remifentanil 0.1\~0.3 ug/kg/min are injected intravenously to maintain sedation and assistant analgesia, and cisatracurium besilate 0.02 mg/kg is allowed to add as appropriate. During the operation, the dose of anesthetic drugs is adjusted so that the fluctuation of heart rate and blood pressure did not exceed 20 %.
Drug: Remimazolam · Drug: Fentanyl · Drug: Cisatracurium Besylate · Drug: Remifentanil
1. Induction of anesthesia After the sevoflurane volatilization tank is adjusted to 8 % and the fresh gas flow rate is 5 L/min, the suitable mask connects with the outlet of the loop and covers the nose of the child. After the LoC, the sevoflurane volatilization tank is set to 3 % and the fresh gas flow rate is 2 L/min to maintain autonomous respiration. At the same time, fentanyl 3-4 ug/kg and cisatracurium besilate 0.1 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope. 2. Maintenance of anesthesia Continuous inhalation of sevoflurane concentration 2 %-3 % and remifentanil 0.1-0.3 ug/kg/min intravenous pump to maintain sedation and assistant analgesia, and cisatracurium besilate 0.02 mg/kg is allowed to add as appropriate. During the operation, the dose of anesthetic drugs is adjusted so that the fluctuation of heart rate and blood pressure did not exceed 20 %.
Drug: Sevoflurane · Drug: Fentanyl · Drug: Cisatracurium Besylate · Drug: Remifentanil
Anesthesia was induced with Remimazolam 0.4-0.8 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC), followed by remimazolam 1-2 mg/kg/h until the end of surgery.
Anesthesia was induced with 8 % Sevoflorane by sevoflurane volatilization tank until the loss of consciousness (LoC), followed by 2 %-3 % Sevoflorane until the end of surgery.
Anesthesia was induced with fentanyl 3-4 ug/kg by intravenous injection after the LoC.
Anesthesia was induced with cisatracurium besilate 0.1 mg/kg by intravenous injection after the LoC. And the cisatracurium besilate 0.02 mg/kg is allowed to add as appropriate during the operation.
After the LoC, remifentanil 0.1\~0.3 ug/kg/min inject intravenously until the end of surgery.
The incidence of emergence agitation
The PAED scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score. PAED scale \>12 at any time indicates presence of emergence agitation.
Time frame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
The incidence of emergence agitation
The Watcha scale consists of four items and scores \>2 at any time indicates presence of emergence agitation.
Time frame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
The incidence of emergence agitation
The 5-point scale consists of five items. The scores ≥4 and lasts for more than 5 minutes indicate presence of emergence agitation.
Time frame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
Systolic pressure
"30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward".
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Diastolic pressure
"30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward".
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Mean pressure
"30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward".
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Heart rate
"30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward".
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Recovery times
The period from discontinuation of anesthetic drugs to the recovery of the child's self-consciousness and can respond correctly to external stimuli.
Time frame: Up to 30 minutes after operation
Delayed emergence
Delayed emergence is defined as failure to shake hands and no significant response to nociceptive stimuli more than 30 minutes after surgery.
Time frame: Up to 30 minutes after operation
Postoperative Pain
The FLACC scale consists of fIve items. Each item is scored 0-2 yielding a total between 0 and 10. The degree of pain increased directly with the total score.
Time frame: During the recovery from anesthesia.
Complication
All the perioperative complications are recorded.
Time frame: During the perioperative period
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Second Affiliated Hospital of Nanchang University