Reversal With Low Doses of Sugammadex in Patients Undergoing Non-cardiac Surgery

NCT ID: NCT03460509

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2019-12-31

Brief Summary

Neuromuscular blocking agents (NMBA) are among the most commonly used drugs during general anesthesia and may induce complete muscle paralysis.They are used clinically to facilitate endotracheal intubation and to optimize surgical working conditions. Incomplete recovery from non-depolarising NMBAs continues to be a common problem in modern postoperative care unit and is associated with significant risk of microaspiration and hypoventilation which leads to pulmonary complications.Recently effective reversal of neuromuscular blockade has been described by use of lower dose of sugammadex the recommended without providing adequate answer to whether the lower dose is safe enough to avoid recurrent block.

Hypotheses:

1. Administration of sugammadex 0.25 mg/kg at TOF ratio 0.3 will successfully reverse (TOF=0.9) rocuronium induced neuromuscular block within 10 min.

2. Recurrent block (TOF ratio < 0.9) does not occur after reversal with low dose sugammadex 0.25 mg/kg.

The primary objective of this trial is to assess the dose-response characteristics of sugammadex in reversing rocuronium induced neuromuscular block and to identify the minimal effective dose

Secondary objective is to assess the safety of different doses of sugammadex (recurrent block (TOF ratio < 0.9) after reversal and the occurrence of adverse reactions)

Sugammadex is a very expensive drug which limits its use i anaesthesia department. By optimising drug dosage it may have economic impact and contribute to a wider use of sugammadex to reverse neuromuscular block before extubation and thus avoid incomplete recovery. This may lead to less risk for postoperative pulmonary complications and thereby reduce morbidity and mortality after surgery.

Detailed Description

Doses of study drug will be 0 mg/kg Ideal Body Weight (IBW), 0.25 mg/kg IBW, 0.50 mg/kg IBW, 1.0 mg/kg IBW and 2.0 mg/kg IBW. TOF will be measured every 10th second until full reversal.

Conditions

Postoperative Residual Curarization; Neuromuscular Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sugammadex 0 mg/kg

Placebo NaCl 0,9%

Group Type: PLACEBO_COMPARATOR

Sugammadex

Intervention Type: DRUG

Dose-response

Sugammadex 0,25 mg/kg

Sugammadex 0.25 mg/kg IBW

Group Type: ACTIVE_COMPARATOR

Sugammadex

Intervention Type: DRUG

Dose-response

Sugammadex 0,5 mg/kg

Sugammadex 0.50 mg/kg IBW

Group Type: ACTIVE_COMPARATOR

Sugammadex

Intervention Type: DRUG

Dose-response

Sugammadex 1mg/kg

Sugammadex 1.0 mg/kg IBW

Group Type: ACTIVE_COMPARATOR

Sugammadex

Intervention Type: DRUG

Dose-response

Sugammadex 2mg/kg

Sugammadex 2 mg/kg IBW

Group Type: ACTIVE_COMPARATOR

Sugammadex

Intervention Type: DRUG

Dose-response

Interventions

Sugammadex

Dose-response

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient, both genders, undergoing any elective in-hospital surgical procedure under general anesthesia requiring rocuronium neuromuscular block.
• ASA I-IV
• Signed informed consent

Exclusion Criteria

• Patient less than 18 years of age
• Patient participating in another clinical study which could interfere with TOF trial.
• Patient with neuromuscular disease
• Patient from ICU
• BMI > 30.0 kg/m2
• Patient scheduled for local or regional anesthesia only
• Patient undergoing general anesthesia without rocuronium
• Patient with hypersensitivity to NMBAs or sugammadex. Also hypersensitivity to any active substance or to any of the following excipient: Hydrochloric acid 3.7% (to adjust pH) and/or sodium hydroxide (to adjust pH) Water for injections .
• Renal dysfunction (GFR<30 mL/min/1,73m2)
• Hepatic dysfunction
• Patient who have received sugammadex in the last 24 h.
• Pregnant or breastfeeding woman. Women in childbearing age must have a negative pregnant test before inclusion.
• Bradycardia (puls <40)
• Hypotension (Systolic BP <90 mmHg)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital of Vestfold

OTHER

Sponsor Role: lead

Responsible Party

Tayyba Aslam

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Tayyba Aslam, MD

Role: CONTACT

tayybaaslam@gmail.com

004798097489

Espen Lindholm, MD, PHD

Role: CONTACT

espen.lindholm@siv.no

004792213346

Other Identifiers

SIVAA01

Identifier Type: -

Identifier Source: org_study_id