A Phase 4 interventional study of Rocuronium and Sugammadex in Surgery and Postoperative Pain, sponsored by Algemeen Ziekenhuis Maria Middelares. Withdrawn at 1 site in Belgium. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by Algemeen Ziekenhuis Maria Middelares · Phase 4, Interventional, and Treatment
During Total hip replacement arthroplasty (THA), the hip joint first must be luxated in order to have access to the joints. A lot of force and torque must be carried out on the joint to perform this manipulation. This is both difficult for the surgeon and may cause additional tissue damage and postoperative pain. After placement of the prosthesis and reduction of the joint, the tension of the hip joint must be evaluated by the surgeon to ascertain the adequacy of the prosthesis. During luxation, minimal muscle tension would be ideal, while after reduction of the joint, normal muscle tension is desired to permit assessment of the mechanics of the hip joint.
The aim of the study is to investigate whether deep neuromuscular block, combined with a reversal before mechanics assessment improves surgical conditions, surgical time, and postoperative patient comfort.
2X20 patients are randomised: Rocuronium-group (R-group) and Placebo-group (P-group).
All patients receive standardised multimodal intravenous analgesia. After standardised induction of anasthesia and patient positioning, the patient is administered either placebo or rocuronium 0.9 mg/kg, followed by continuous infusion of either placebo or rocuronium 0.4 mg/kg/h. 1 minute before reduction of the hip joint, the patient is administered either sugammadex (R-group) or placebo (P-group) for full reversal of the neuromuscular block.
During the surgery, time points are recorded for: incision, start luxation of the joint, start reduction of the joint, start skin closure.
The surgeon is blinded for patient allocation. At three moments (after luxation, just before reduction of the joint, and after assessment of joint mechanics), the surgeon is asked to appraise the surgical conditions on an analogue scale.
Postoperative analgesic consumption and pain scores are recorded. VAS scores for knee pain and hip pain are assessed before surgery, at the moment of discharge from the post-anesthesia care unit (=D0), the morning after surgery (=D1), at D2, and at D7.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
Browse Pain, Postoperative studies →Algemeen Ziekenhuis Maria Middelares is the lead sponsor of 37 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo alternative for rocuronium and for sugammadex
Drug: Placebo
Rocuronium as bolus and in syringe pump Sugammadex just before reduction of the joint
Drug: Rocuronium · Drug: Sugammadex
rocuronium is administered in bolus and continuous infusion
Also known as: Esmeron
Sugammadex is administered just before reduction of the joint
Also known as: Bridion
Placebo is administered as alternative to rocuronium in a bolus and in a syringe pump. Placebo is administered as alternative to sugammadex
Also known as: Saline 0.9%
Surgical conditions during luxation on a four-grade numeric scale
Excellent - good but not optimal - poor but acceptable - unacceptable
Time frame: during surgery, during luxation of the joint
Patient reported pain scores on a VAS score (0-100 ; 0=no pain , 100=worst pain)
Patient reported pain scores in knee and hip after surgery at day 0-1-2-7
Time frame: day 0-1-2-7 (day 0 = day of surgery)
surgery time
time (in minutes) of surgery between incision and reduction, and between reduction and skin closure
Time frame: during surgery
Surgical conditions during reduction of the joint on a four-grade numeric scale
Excellent - good but not optimal - poor but acceptable - unacceptable
Time frame: during surgery, during reduction of the joint
Surgical conditions for assessment of joint kinetics on a four-grade numeric scale
Excellent - good but not optimal - poor but acceptable - unacceptable
Time frame: during surgery, after reduction of the joint
Plan to share: Undecided — scores of surgical conditions patient-reported pain scores data about surgery time
No publications or documents are linked to this record.
Start is estimated for Dec 2017; primary completion for Apr 2018, 4 months later.
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This study is withdrawn, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Rocuronium · Sugammadex
Algemeen Ziekenhuis Maria Middelares