Depth of Neuromuscular Blockade and the Perioperative Conditions in Laparoscopic Surgery in Pediatric Population

NCT02546843 | Completed DMC

• 1 other identifier: KDAR FN Brno
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized study prospectively evaluates our experience with administration of cisatracurium and rocuronium antagonized by sugammadex and evaluates the effects of various depths of neuromuscular blockage on providing optimal surgical conditions during laparoscopy with low-pressure capnoperitoneum.

Conditions

Neuromuscular Blockade

Keywords

rocuronium; sugammadex; pediatric anesthesia; cisatracurium; surgical conditions

Outcome Measures

Primary Outcomes (1)

• Surgical scoring system

  During the surgery the blinded surgeon will grade surgical conditions due to surgical scoring system

  intraoperatively

Secondary Outcomes (1)

• Number of adverse events

  intraoperatively

Study Arms (2)

Group A

EXPERIMENTAL

After anesthesia induction: intravenous cannulation, preoxygenation, sufentanil 0.2 μg/kg intravenously, propofol 2.0mg/kg the neuromuscular blockade will be induced with rocuronium 0.6 mg/kg (1 mg/kg only in a case of a rapid sequence induction). maintaining the depth of neuromuscular blockade - rocuronium: the appropriate depth of the block will be maintained with repeated boluses of rocuronium 0.3 mg/kg according to TOF 0, PTC 0-1. Specific Neuromuscular Blockade reversal will be performed with Sugammadex intravenously. The proper dosage of sugammadex will depend on the depth of the blockade:at TOF -1-2 (train-of-four) 2m g/kg, if TOF 0 and PTC(post-tetanic count) 0-1 4mg/kg of sugammadex will be administered

Drug: Rocuronium; Drug: Specific Neuromuscular Blockade reversal; Drug: maintaining the depth of neuromuscular blockade - rocuronium

Group B

ACTIVE COMPARATOR

After anesthesia induction: intravenous cannulation, preoxygenation, sufentanil 0.2 μg/kg intravenously, propofol 2.0mg/kg the neuromuscular blockade will be induced with cisatracurium 0.15mg/kg intravenously. Maintaining the depth of neuromuscular blockade - cisatracurium:the appropriate depth of the block will be maintained with repeated boluses of cisatracurium 0.03 mg/kg - according to TOF maintaining of muscular relaxation TOF 1. Nonspecific Neuromuscular Blockade reversal will be performed with neostigmine 0.03 mg/kg and atropine 0.02 mg/kg intravenously, the reversal will be applicated in case of TOF 1 or higher.

Drug: Cisatracurium; Drug: Nonspecific Neuromuscular Blockade reversal; Drug: maintaining the depth of neuromuscular blockade - cisatracurium

Interventions

Rocuronium DRUG

rocuronium 0.6 mg/kg intravenously (1 mg/kg only in a case of a rapid sequence induction)

Also known as: Esmeron

Group A

Cisatracurium DRUG

cisatracurium 0.15mg/kg intravenously

Also known as: Nimbex

Group B

Nonspecific Neuromuscular Blockade reversal DRUG

neostigmine 0.03 mg/kg and atropine 0.02 mg/kg intravenously

Group B

Specific Neuromuscular Blockade reversal DRUG

Sugammadex intravenously aimed to reverse the neuromuscular blockade.According to neuromuscular blockade monitoring: at TOF - (train-of-four) 2m g/kg, if TOF 0 and PTC(post-tetanic count) 0-1 4mg/kg of sugammadex will be administered

Group A

maintaining the depth of neuromuscular blockade - rocuronium DRUG

repeated boluses of rocuronium 0.3 mg/kg will be administered to maintain the muscular blockage - according to TOF 0, PTC 0-1

Also known as: neuromuscular blockade

Group A

maintaining the depth of neuromuscular blockade - cisatracurium DRUG

repeated boluses of cisatracurium 0.03 mg/kg will be administered to maintain the muscular blockage - according to TOFmaintaining of muscular relaxation TOF 1

Also known as: neuromuscular blockade

Group B

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• pediatric patients aged 2 to 17 years (+ 364 days) eligible for laparoscopy (diagnostic laparoscopy, appendectomy, cholecystectomy, nephrectomy, splenectomy, tumor biopsy, varicocele correction, testicular retention)
• fasting of at least 6 hours
• ASA (American Society of Anesthesiology score) score 1 or 2
• signed informed consent of the legal guardian of the patient

You may not qualify if:

• disagreement of the patient or his/her legal guardian
• serious comorbidities - renal or hepatic disorders
• ASA score ≥ 3

Sponsors & Collaborators

• Brno University Hospital: lead
• KDCHOT FN Brno: collaborator

Study Sites (1)

University Hospital Brno - FN Brno

Brno, Czech Republic, 62500, Czechia

Location

MeSH Terms

Interventions

Rocuronium; cisatracurium; Neuromuscular Blockade

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Anesthesia and Analgesia; Investigative Techniques

Study Officials

• Petr Štourač, MD, Ph.D

  KDAR FN Brno

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Ph.D

Study Record Dates

• First Submitted: September 5, 2015
• First Posted: September 11, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: May 1, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

CZ (1)