Perioperative Intravenous Nimodipine Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Ioannina
About this trial
The role of perioperative IV administration of nimodipine, an L-type calcium channel antagonist which is capable of crossing the blood-brain barrier, on peri-operative opioid and anesthetics requirements, pain intensity, opioid-related side effects and early postoperative bowel mobility in patients undergoing surgical treatment for bowel cancer with open radical colectomy remains scarcely explored. A prospective double-blind, randomized controlled trial investigating the effect of perioperative IV administration of nimodipine in patients undergoing open colectomy for cancer treatment is therefore conducted.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for open surgical treatment of bowel cancer at the General Hospital of Patra
Disqualifiers
Age < 18 years, > 75 years
American Society of Anesthesiologists (ASA) physical status > III
Allergy to nimodipine
Inability to provide informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
Nimodipine
DrugA continuous dose of 2 mg/h (10 ml/h) of nimodipine solution will be administered continuously one (1) h prior to start of operation until 24 h after the end of the procedure.
Isotonic Saline
DrugA continuous dose of 10 ml/h of normal saline solution will be administered continuously one (1) h prior to start of operation until 24 h after the end of the procedure.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: NimodipineExperimental treatment 1 intervention
Group B: Isotonic salinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intraoperative Remifentanil Consumption
Remifentanil will be administered intraoperatively based on qNOX (quantum NOXious stimulus index) levels, which will be maintained between 40 and 60. qNOX values below 40 will prompt a reduction in remifentanil dosing, while values above 60 will prompt an increase, in order to optimize analgesia.
Time frame
Intraoperative period, defined as the time (in minutes) from induction of general anesthesia to extubation.2
Intraoperative propofol consumption
Propofol will be administered intraoperatively based on BIS (Bispectral Index) and qCON (quantum Consciousness Index) values, which will be maintained between 40 and 60. BIS or qCON values below 40 will prompt a reduction in propofol dosing, while values above 60 will prompt an increase, in order to maintain appropriate depth of anesthesia.
Time frame
Intraoperative period, defined as the time (in minutes) from induction of general anesthesia to extubation.3
Cumulative opioid consumption within 0 to 72 hours postoperatively
Cumulative morphine consumption (mg) during the first 72 hours after arrival at the Post Anesthesia Care Unit (PACU). During the first hour in the PACU, morphine will be administered using a titration method. Following transfer to the surgical ward, a patient-controlled analgesia (PCA) device will be used to monitor morphine consumption. Cumulative opioid use will be recorded at specific time points: 3, 6, 12, 18, 24, 30, 36, 48, 60, and 72 hours postoperatively.
Time frame
From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.Secondary outcomes
1
Pain intensity at rest
Pain intensity at rest will be assessed using the Numerical Rating Scale (NRS; 0-10), starting upon arrival at the Post Anesthesia Care Unit (PACU) and continuing at the following postoperative time points on the ward: 3, 6, 12, 18, 24, 30, 36, 48, 60, and 72 hours.
Time frame
From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.2
Pain intensity during coughing
Pain intensity during coughing will be assessed using the Numerical Rating Scale (NRS; 0-10), beginning upon arrival at the Post Anesthesia Care Unit (PACU) and at the following postoperative time points on the ward: 3, 6, 12, 18, 24, 30, 36, 48, 60, and 72 hours.
Time frame
From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.3
Opioid related sedation
Number of participants with postoperative sedation assessed using the Ramsay Sedation Scale (range: 1 = anxious/agitated to 6 = no response to stimulus).
Time frame
From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.4
Opioid related pruritus
Number of participants with documented pruritus related to opioid use, recorded as a binary outcome variable (yes/no).
Time frame
From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.Sponsors and contacts
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Source ClinicalTrials.gov