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

Sponsor

The Hospital of Vestfold (Other)

Overall Status

Unknown status

CT.gov ID

NCT03460509

Collaborator

(none)

144

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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:

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.
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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Residual Curarization Neuromuscular Block	Drug: Sugammadex	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized Double Blind Trial Comparing Reversal With Low Doses Of Sugammadex aFter Rocuronium-induced Neuromuscular Block Under General Anesthesia in Patients Undergoing Non-cardiac Surgery(TOF TRIAL)

Anticipated Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Sugammadex 0 mg/kg Placebo NaCl 0,9%	Drug: Sugammadex Dose-response
Active Comparator: Sugammadex 0,25 mg/kg Sugammadex 0.25 mg/kg IBW	Drug: Sugammadex Dose-response
Active Comparator: Sugammadex 0,5 mg/kg Sugammadex 0.50 mg/kg IBW	Drug: Sugammadex Dose-response
Active Comparator: Sugammadex 1mg/kg Sugammadex 1.0 mg/kg IBW	Drug: Sugammadex Dose-response
Active Comparator: Sugammadex 2mg/kg Sugammadex 2 mg/kg IBW	Drug: Sugammadex Dose-response

Outcome Measures

Primary Outcome Measures

The time from study drug administration to reaching a TOF ratio of 0.9. [10 minutes]

Secondary Outcome Measures

Number of patient with reoccurrence of neuromuscular block after initial reversal to TOF ratio 0.9. [20 minutes]
Number of patients with adverse reactions in each group [until discharge - 3 days]
Adverse reactions (anaphylactic reaction, flushing, urticaria, erythematous rash, (severe) hypotension (BPsyst> 75 mmHg), tachycardia (heart rate> 120 beats/min), bradycardia (heart rate <40 beats/min), swelling of tongue, swelling of pharynx, bronchospasm)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Hospital of Vestfold

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tayyba Aslam, Principal investigator, The Hospital of Vestfold

ClinicalTrials.gov Identifier:

NCT03460509

Other Study ID Numbers:

SIVAA01

First Posted:

Mar 9, 2018

Last Update Posted:

May 30, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Delayed Emergence from Anesthesia

Study Results

No Results Posted as of May 30, 2018