CLINICAL TRIAL

Rocuronium IV bolus 0.1 mg/kg guided by TOF 0/4 and PTC≤ 2 for Laparoscopic Colorectal Surgeries

Recruiting · 18+ · All Sexes · Montréal-Est, Canada

This study is evaluating whether a drug called NMB has a positive impact on pain and recovery after surgery.

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About the trial for Laparoscopic Colorectal Surgeries

Treatment Groups

This trial involves 2 different treatments. Rocuronium IV Bolus 0.1 Mg/kg Guided By TOF 0/4 And PTC≤ 2 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Rocuronium IV bolus 0.1 mg/kg guided by TOF 0/4 and PTC≤ 2
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Rocuronium IV bolus 0.1 mg/kg guided by TOF that must remain between 1-3 during surgery
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
ASA1-3 patients
fully consented
BMI < 35
Age > 18yo
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: every 30 minutes from T0 = arrival in PACU until discharge from PACU, up to 3 hours
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: every 30 minutes from T0 = arrival in PACU until discharge from PACU, up to 3 hours.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Rocuronium IV bolus 0.1 mg/kg guided by TOF 0/4 and PTC≤ 2 will improve 1 primary outcome and 22 secondary outcomes in patients with Laparoscopic Colorectal Surgeries. Measurement will happen over the course of Intra-operative (from T0 incision until Tend = start dressing).

Number of times NOL index passes over the threshold of 25, number, no unit
INTRA-OPERATIVE (FROM T0 INCISION UNTIL TEND = START DRESSING)
To compare the number of times NOL index passes over the threshold of 25 (considered as painful threshold in an anesthetized patient) during anesthesia in group D versus M
Total intra-operative remifentanil consumption during surgery in mcg/kg/h
INTRA-OPERATIVE (FROM T0 INCISION UNTIL TEND = START DRESSING)
To compare total intra-operative remifentanil consumption (in mcg per hour from T0 incision until Tend = start dressing) during anesthesia for laparoscopic colorectal surgery between two groups: Group "D" for Deep muscle relaxation and group "M" for Moderate muscle relaxation
Area Under the Curve (AUCs) whenever the NOL is above 25, no unit
INTRA-OPERATIVE (FROM T0 INCISION UNTIL TEND = START DRESSING)
To compare the Area Under the Curve (AUCs) of all the intraoperative periods for which the NOL index will be above the pain threshold of 25 from T0 until Tend
Time for awakening and extubation in seconds
INTRA-OPERATIVE (FROM T0 INCISION UNTIL TEND = START DRESSING)
To compare the time for awakening and extubation (performed for all patients in the Operating Room, OR) between group D and M
Total intraoperative time from T0 until Tend with NOL above 25 in minutes
INTRA-OPERATIVE (FROM T0 INCISION UNTIL TEND = START DRESSING)
To compare the total intraoperative time in minutes from T0 until Tend with NOL index above 25, with NOL index between 10 and 25, and with NOL index below 10 in group D versus M
Abdominal insufflation duration in minutes
INTRA-OPERATIVE (FROM T0 INCISION UNTIL TEND = START DRESSING)
To compare the time in minutes spent with abdominal insufflation and laparoscopic surgery between group D and M
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Who is running the study

Principal Investigator
P. R.
Prof. Philippe Richebe, MD PhD
Ciusss de L'Est de l'Île de Montréal

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get laparoscopic colorectal surgeries a year in the United States?

About 12,500 new surgical cases are done each year at community hospitals practicing this laparoscopic surgery, and about 3.5,000 procedures at hospitals practicing open colorectal surgery. The present findings suggest that in the United States about 733 procedures are carried out per 100,000 patients, and that of these, 20% are laparoscopic colorectal.

Anonymous Patient Answer

What are the signs of laparoscopic colorectal surgeries?

For the first time, clinical signs and symptoms were evaluated by means of a questionnaire of the laparoscopy patients in three clinical studies that took place shortly before the launch of the European Commission (see "European guidelines for surgical indications to use laparoscopy in colorectal cancer" in 2008 for further information). The most frequent signs were the following: pain during peristaltic movements of the abdominal wall muscles; painful movements, such as shivering, when abdominal wall muscles is stimulated.

Anonymous Patient Answer

What causes laparoscopic colorectal surgeries?

Laparoscopic colorectal surgeries could be performed safely and effectively without decreasing the overall quality of life of patients by eliminating intra- and post-operative postural disturbances and postural pain.

Anonymous Patient Answer

What are common treatments for laparoscopic colorectal surgeries?

Current management of [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) has improved significantly with the improvement in imaging techniques. Surgery can be a highly effective method to eradicate the disease in patients with localized or borderline cancers, if the patient is an appropriately selected candidate after proper patient education and careful pre-operative estimation. Also, laparoscopic procedures are associated with shorter hospital stays, quicker recovery and recovery time, reduced need for analgesic and anesthetic drugs, and less post-operative nausea and vomiting. Minimally-invasive techniques can benefit patients with chronic liver disease and renal insufficiency. Laparoscopic colorectal surgery appears to be a safe and applicable treatment option in appropriate candidates.

Anonymous Patient Answer

What is laparoscopic colorectal surgeries?

Laparoscopic colorectal cancer is safe when performed under the right conditions and after the proper training of the surgeon. However, a long recovery time is required and the recurrence pattern remains similar to that of open surgery.

Anonymous Patient Answer

Can laparoscopic colorectal surgeries be cured?

The current study found that the rate of recurrence rate between laparoscopic colectomy and open colectomy in terms of the rate of recurrence of adhesions is similar, and the rate of recurrence rate of adhesions between laparoscopic colectomy and open colectomy in terms of the rate of recurrence of adhesions between a laparoscopic colectomy and an open colectomy are high.

Anonymous Patient Answer

Has rocuronium iv bolus 0.1 mg/kg guided by tof 0/4 and ptc≤ 2 proven to be more effective than a placebo?

There was no difference between the rocuronium iv bolus 0.1 mg/kg guided by tof> 0/4 and ptc≤2 and the rocuronium iv bolus 0.1mg/kg guided by tof> 0/4 and ptc≤2 in children undergoing laparoscopic colorectal surgery.

Anonymous Patient Answer

What is the primary cause of laparoscopic colorectal surgeries?

The most common indications were large polyps, neoplasia of the colon wall and adhesions/inflammatory bowel diseases. Laparoscopic colorectal surgery is done with the intention of reducing morbidity and improving the oncological outcome. The most popular procedure is right hemicolectomy.

Anonymous Patient Answer

What are the common side effects of rocuronium iv bolus 0.1 mg/kg guided by tof 0/4 and ptc≤ 2?

Ropacitonium 0.1 mg/kg and rocuronium 0.5 mg/kg were effective for induction and were associated with a low incidence of both PONV and severe PONV when compared with 0.1 mg/kg rocuronium. Findings from a recent study suggest that rocuronium 0.

Anonymous Patient Answer

Who should consider clinical trials for laparoscopic colorectal surgeries?

In patients who were candidates for laparoscopic colorectal surgery, this study suggests that the following were correlated with increased likelihood of participation in a clinical trial: higher BMI, lower ASA score at time of operation, and higher hemoglobin level at time of surgery.

Anonymous Patient Answer

Have there been any new discoveries for treating laparoscopic colorectal surgeries?

Although new surgical techniques are being used to reduce the use of CO2 for laparoscopic surgery, only a few studies comparing laparoscopic versus open surgery as well as studies comparing the benefits and harms of various surgical techniques. There is room for study of more specific areas of laparoscopic colorectal surgery with a larger sample size. A multi-institutional randomized prospective study with large sample size would be the ideal method of performing such studies.

Anonymous Patient Answer

What are the latest developments in rocuronium iv bolus 0.1 mg/kg guided by tof 0/4 and ptc≤ 2 for therapeutic use?

Rocuronium is safe and effective 0.1 mg/kg after the guidance of tof = 0/4 and ptc = 2 in early surgical patients, because it can relax tracheal muscles to the concentration of 2.5 μg/ml without the effect at the same time.

Anonymous Patient Answer
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