The main aim of the present study is i)To assess whether sugammadex has a positive effect on the post-operative alertness of the patients, and ii) to assess the nature, magnitude and the time of onset of this effect (if any).
ID
Source
Brief title
Condition
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At baseline (1 day before surgery), and 30, 60, and 120 minutes after the TOF
ratio of ~0,9 has been reached, the following commonly used, and non-invasive
cognitive evaluations/scoring lists will be carried out in a subsequent order
to assess recovery and psychomotor function:
Modified Aldrete score
The modified Aldrete score (see Appendix 2) assesses the degree of
post-anesthesia recovery, based on ability to move extremities, respiration and
circulation status, consciousness and oxygen saturation. Each item is scored
from 0 (poor) to 2 (good). >=9 points are needed for recovery to be confirmed,
i.e. the patient is ready for discharge from the PACU.
Trail making test
This test is used to measure visual conceptual and visual motor tracking 29.
Normally, the entire test can be completed in 5 to 10 minutes. Only part A of
this test will be performed. Since it is a test of speed, the examiner must
stress the importance of time and efficiency. Part A consists of encircled
numbers from 1 to 25 randomly spread across a sheet of paper. The object of the
test is for the subject to connect the numbers in order, beginning with 1 and
ending with 25, in as little time as possible. The number of failures to
connect and the distance from the actual line to the number will be determined.
Maddox wing test
With the Maddox Wing instrument an imbalance in the extra-ocular muscles of the
eyes (degree of strabismus) will be measured, where the field of vision is
divided by oblique and vertical wings such that the arrow is seen by the right
eye and a numbered scale in prism diopters by the left.
Visual Analogue Scales for patient and observer to rate post-operative
alertness and recovery.
Secondary outcome
Additional relevant data to be collected include gender, age, relevant medical
history, type of surgery, anticipated duration of surgery, total dose of
propofol and remifentanil, total dose of rocuronium, time of rocuronium
administration(s) relative to start of anesthesia (T=0), other drugs
administered for medical reasons that could influence the outcome of the study
evaluations, end of surgery relative to T=0, time TOF~ 0,9 has been reached
relative to T=0, time start and end of evaluations relative to T=0, any
perioperative complication, and adverse events.
Background summary
The number of ambulatory surgical procedures is increasing rapidly. Surgery
without one or more overnight stays in the hospital is appreciated by most
patients and has considerable economic and efficiency advantages. Recovery from
outpatient anesthesia includes dissipation of anesthetics agents, normalization
of physiological function, observation for medical or surgical complications,
treatment of immediate side effects of anesthesia and surgery and, ultimately,
discharge and return home. Street fitness implies that the patient is not only
ready to go home, but is also capable of safely taking part in the traffic. A
full recovery of cognitive functions is part of this stage. Neuromuscular
blocking agents (NMBAs) are commonly used during surgery to facilitate
endotracheal intubation, allow assisted or controlled ventilation, and let
surgery proceed easily. Sugammadex (Bridion®) is approved in Europe for routine
clinical use to reverse neuromuscular blockade induced by steroidal
non-depolarizing muscle relaxants and has been registered in the Netherlands
since 2008. Several anesthesiologists from all over the world, have
independently reported that patients seem to be more alert in the early phase
of recovery after reversal of NMB with sugammadex compared to reversal with a
cholinesterase inhibitor or spontaneous recovery. However, these observations
have not been substantiated in a clinical study.
Study objective
The main aim of the present study is i)To assess whether sugammadex has a
positive effect on the post-operative alertness of the patients, and ii) to
assess the nature, magnitude and the time of onset of this effect (if any).
Study design
This is a randomized, controlled observer-blind single centre phase IV study.
Upon After stratification for type of surgery and age patients will be
randomized to receive sugammadex (arm A), neostigmine/atropine (Arm B) or no
reversal agent (arm C).
Intervention
Anesthesia will be standardized according to the usual protocol. At the end of
the surgery when TOF ratio is ~0,9, and approximately 70-80% of nicotine
receptors are still blocked by rocuronium, patients will receive either
sugammadex (2 mg/kg iv), neostigmine,04 mg/kg iv plus atropine 0.015 mg/kg iv,
or no reversal agent.
Study burden and risks
Anesthesia and surgical procedures will be according to the usual clinical
procedures. At the end of the surgery, patients will either receive sugammadex,
or neostigmine plus atropine to reverse neuromuscular blockade (both drugs are
registered, safe and commonly used in daily clinical practice), or no reversal
agent.
At basline (1 day before surgery, and at 30, 60 and 120 minutes after the end
of the operation), a serie of non-invasive (cognitive) assessments will be
assessed to evalluate post operatve alertness and recovery. Expected duration
is 15-20 minutes per measuring moment (in total 4 measuring moments). Outcomes
of this present study will provide insight if the administration of sugammadex
will positively affect post operative alertness and recovery which may have
important cllinical and economical implications.
Geert Grooteplein Zuid 10
6525 GA Nijmegen
NL
Geert Grooteplein Zuid 10
6525 GA Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- Males and females.
- Age 18-65 years.
- Able to perform the study assessments.
- ASA classification 1 or 2
- Medical need for general anesthesia and neuromuscular blockade.
- NMB with the standard dose of rocuronium. If the surgery lasts longer than 75 minutes the patient will be excluded.
- Minor surgical and gynecological procedures that require tracheal intubation and mechanical ventilation.
- Signed informed consent.
Exclusion criteria
- Contra-indications for rocuronium, sugammadex, neostigmine and/or atropine.
- Concomitant conditions or diseases that might interfere with the study assessments.
- Concomitant treatment with any experimental drug within 4 weeks before surgery.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-000157-23-NL |
| CCMO | NL35385.091.11 |