Deep Neuromuscular Blockade on Postoperative Pain
ConditionNeuromuscular Blockade
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-7
SponsorSeoul National University Hospital
About this trial
This study aims to investigate the impact of varying degrees of neuromuscular blockade on postoperative pain in pediatric patients aged over 2 months to under 7 years undergoing laparoscopic surgery under general anesthesia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patients aged over 2 months to under 7 years scheduled for laparoscopic surgery under general anesthesia.
American Society of Anesthesiologists (ASA) Physical Status Classification I, II, or III.
Disqualifiers
Patients undergoing emergency surgery.
Patients with chronic pain or currently taking analgesics for chronic pain.
Known hypersensitivity to general anesthetic agents or analgesics.
Patients with underlying cardiovascular disease.
Trial design
Design model
Parallel
Treatments tested in this trial
rocuronium 0.2 mg/kg/hr continuous infusion
DrugTo maintain Train-of-four count 1 to 3 during surgery: Administration of continuous infusion of rocuronium at a rate of 0.2 mg/kg/hr to achieve and sustain moderate neuromuscular blockade.
rocuronium 0.6 mg/kg/hr continuous infusion
DrugTo maintain Train-of-four count 0 during surgery: Administration of continuous infusion of rocuronium at a rate of 0.6 mg/kg/hr to achieve and sustain deep neuromuscular blockade.
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: moderate neuromuscular blockadeActive comparator 1 intervention
Group B: deep neuromuscular blockadeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ANIm (Analgesia Nociception Index) Value
Time frame
30 minutes after arrival in the recovery roomSecondary outcomes
1
FLACC Pain Scale
Time frame
30 minutes after arrival in the recovery room2
Pediatric Anesthesia Emergence Delirium Scale
Time frame
30 minutes after arrival in the recovery room3
Time to Extubation
Time frame
From end of surgery to extubation (in minutes, assessed up to 1 hour)4
Recovery Room Length of Stay
Time frame
Duration of stay in the recovery room (in minutes, assessed up to 2 hours)Sponsors and contacts
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Source ClinicalTrials.gov