Reversal of Pipecuronium-induced Neuromuscular Blockade With Sugammadex During Sevoflurane Anesthesia

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTamas Vegh, MD

About this trial

Safety during modern practice of anaesthesia is of great concern. Patients admitted daily for surgical procedures undergoing general anaesthesia for different types of operations are exposed to different risks, starting from the anaesthesia and ending with the surgical intervention. Aim of the study is to provide a comprehensive and evidence based data regarding the safety of the neuromuscular blocking agents used in modern anaesthesia practice, precisely Rocuronium and Pipecuronium, as well as the reversal agents such as Sugammadex, which is the sole agent in use in practice nowadays. A routine anaesthetic practice will be performed during the whole period of our study after strict patient selection criteria. Intraoperative standard monitoring as per local and international guidelines will be applied, this includes Spo2, ECG, NIBP/IBP, etCO2, BIS and Tetragaph for neuromuscular blockade monitoring. After induction of anaesthesia and prior to the administration of the muscle relaxant agent, a TOFC (Train of Four Count) will be registered as the starting point. Throughout the anaesthetic time, there will be continuous TOF monitoring. The anaesthesia will be maintained by sevoflurane. Also, the recruited samples will be divided according to the neuromuscular blockade agents administered, either Rocuronium or Pipecuronium. At the end of the surgical procedure, the time lapse between the administration of the reversal agent Sugammadex and a TOF ratio of 0.9 is registered as our primary end point. TOF measures will be performed in the postoperative period, to make sure there is no residual neuromuscular blockade in the early postoperative phase. The study will not only monitor the safety of the neuromuscular blocking agents in use, but will also monitor any signs of anaphylaxis due to their administration both intra and postoperatively.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

80 adult general surgery and neurosurgical patients are enrolled in the study after giving an informed written consent regarding their participation.

Age: between 18-65 years;

ASA score: 1-3;

BMI 18.5-25 (normal body weight);

Disqualifiers

Diseases affecting neuromuscular function (myopathies, severe liver and kidney failure);

Drugs affecting neuromuscular function (magnesium, aminoglycosides);

Difficult airway, or anticipated difficult intubation;

Pregnancy (a pregnancy test is performed in women of childbearing age to rule out pregnancy);

Trial design

Design model

Parallel

Treatments tested in this trial

  • pipecuronium bromide

    Drug

    Investigation of muscle relaxation with pipecuronium bromide

  • Rocuronium bromide

    Drug

    Muscle relaxation with rocuronium as a control

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Rocuronium bromide as a control muscle relaxant agent in comparison to pipecuronium bromide.Active comparator 1 intervention
Group B: Reversal of pipecuronium induced neuromuscular blockade using sugammadex.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time till TOF ratio of 0.9

The time between the start of sugammadex administration and reaching a TOF ratio of 0.9 will be the primary efficacy endpoint of the study.

Time frame
from reversal to extubation within 5 minutes as per the onset of time of Sugammadex

Secondary outcomes

1

Incidence of residual neuromuscular blockade

The Prevalence of TOF \<0.9 in the postoperative period.

Time frame
30 minutes after extubation

Other outcomes

1

The incidence of allergic/anaphylactic reactions

The incidence of allergic/anaphylactic reactions associated with muscle relaxant and reversal agents' administration.

Time frame
From induction to up to 30 minutes postoperatively
2

Time to achieving a TOF ratio of 1.0

The time elapsed between Sugammadex administration and achieving a TOF ratio of 1.0

Time frame
the time elapsed until the onset of Summadex which is within 5 minutes
3

Doses of the muscle ralaxants

Comparison of sugammadex doses required to reverse the effects of the study focused two muscle relaxants.

Time frame
from induction to reversal according to the surgical time

Sponsors and contacts

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Tamas Vegh, MD

Lead sponsor

University of Debrecen

Sponsor institution

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