Cerebral Oxygenation and Metabolism After Reversal Of Rocuronium: Comparison Between Sugammadex Versus Neostigmine

NCT02944175 | Unknown DMC

• 1 other identifier: MD ∕16.07.22
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cholinesterase inhibitors such as Neostigmine and Edrophonium have been used to reverse neuromuscular blockade after surgery. However, these drugs have a relatively slow onset and have adverse effects associated with stimulation of muscarinic receptors. In addition, neostigmine cannot be used to reverse profound blockade. Anesthetics may exert their effects on various facets of cerebral function such as cerebral metabolic rate (CMRO2), cerebral blood flow (CBF), cerebral blood flow-metabolism coupling, intra cranial pressure (ICP), autoregulation, vascular response to CO2 and brain electrical activity. The net result of all these effects of the anaesthetic agents combined with their systemic effects may prove beneficial or detrimental to an already diseased brain. In neurosurgical patients, clear and rapid recovery is required to early assess the neurological status and to maintain the cerebral oxygenation and metabolism within the normal physiological values which may be saved by sugammadex.

Conditions

Supratentorial Brain Tumor Surgery

Outcome Measures

Primary Outcomes (1)

• Time to recovery of the train-of-four (TOF) ratio to 0.9

  The time from start of administration of sugammadex or neostigmine to recovery of the train-of-four (TOF) ratio to 0.9

  For 1 hour after surgery

Secondary Outcomes (15)

• Arterio-Jugular oxygen content difference

  For 6 hours after the start of surgery

• Estimated cerebral metabolic rate for oxygen (eCMRO2)

  For 6 hours after the start of surgery

• Cerebral Extraction Rate of Oxygen (CEO2)

  For 6 hours after the start of surgery

• Cerebral Blood Flow equivalent (CBFe)

  For 6 hours after the start of surgery

• Heart rate

  For 6 hours after the start of surgery

Study Arms (2)

Sugammadex

EXPERIMENTAL

Patients will receive Sugammadex to antagonise the residual effects of neuromuscular blocking drugs

Drug: Sugammadex

Neostigmine

ACTIVE COMPARATOR

Patients will receive Neostigmine to antagonise the residual effects of neuromuscular blocking drugs

Drug: Neostigmine

Interventions

Sugammadex DRUG

At the end of surgery and when 2 responses were achieved on the TOF stimulation, Sugammadex 2 mg·kg-1 was administered intravenously in Group S

Sugammadex

Neostigmine DRUG

At the end of surgery and when 2 responses were achieved on the TOF stimulation neostigmine 0.05 mg·kg-1 + atropine 0.02 mg·kg-1 was administered intravenously

Neostigmine

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical class status I - III .
• Patients scheduled for elective supratentorial brain tumor resection

You may not qualify if:

• Severe uncompensated cardiac disease.
• Severe uncompensated respiratory disease.
• Severe uncompensated hepatic disease.
• Severe uncompensated renal disease.
• Morbidly obese patients.
• Documented hypersensitivity to one of the used drugs.
• Surgery in sitting position
• Surgery in prone position
• Patients with altered level of consciousness.
• Pregnancy.

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Interventions

Sugammadex; Neostigmine

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Sherif A Mousa

  Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 25, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 19, 2018

Record last verified: 2018-10