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

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)

Sponsors

Lead Sponsor: The Hospital of Vestfold

Source The Hospital of Vestfold
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.

Overall Status Unknown status
Start Date August 2018
Completion Date December 2019
Primary Completion Date December 2019
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
The time from study drug administration to reaching a TOF ratio of 0.9. 10 minutes
Secondary Outcome
Measure Time Frame
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
Enrollment 144
Condition
Intervention

Intervention Type: Drug

Intervention Name: Sugammadex

Description: Dose-response

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Healthy Volunteers: No

Overall Contact

Last Name: Tayyba Aslam, MD

Phone: 004798097489

Email: [email protected]

Verification Date

May 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: The Hospital of Vestfold

Investigator Full Name: Tayyba Aslam

Investigator Title: Principal investigator

Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: Sugammadex 0 mg/kg

Type: Placebo Comparator

Description: Placebo NaCl 0,9%

Label: Sugammadex 0,25 mg/kg

Type: Active Comparator

Description: Sugammadex 0.25 mg/kg IBW

Label: Sugammadex 0,5 mg/kg

Type: Active Comparator

Description: Sugammadex 0.50 mg/kg IBW

Label: Sugammadex 1mg/kg

Type: Active Comparator

Description: Sugammadex 1.0 mg/kg IBW

Label: Sugammadex 2mg/kg

Type: Active Comparator

Description: Sugammadex 2 mg/kg IBW

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

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

Source: ClinicalTrials.gov