Perioperative Intravenous Nimodipine Trial

NCT07048522 | Recruiting

• 1 other identifier: 18-4_2024-12-05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colectomy; Open Surgery; Pain; Pain, Postoperative; Pain, Acute

Outcome Measures

Primary Outcomes (3)

• 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.

  Intraoperative period, defined as the time (in minutes) from induction of general anesthesia to extubation.

• 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.

  Intraoperative period, defined as the time (in minutes) from induction of general anesthesia to extubation.

• 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.

  From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.

Secondary Outcomes (7)

• Pain intensity at rest

  From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.

• Pain intensity during coughing

  From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.

• Opioid related sedation

  From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.

• Opioid related pruritus

  From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.

• Postoperative nausea and/or vomiting (PONV)

  From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.

Study Arms (2)

Nimodipine

EXPERIMENTAL

Prepared (coded) by the pharmacy 50 ml solutions of nimodipine (2 mg/10 ml) with blinded 50 ml syringes will be used in each patient.

Drug: Nimodipine

Isotonic saline

PLACEBO COMPARATOR

Prepared (coded) by the pharmacy 50 ml solutions with blinded 50 ml syringes of isotonic saline will be used in each patient.

Drug: Isotonic Saline

Interventions

Nimodipine DRUG

A continuous dose of 4 mg/h (20 ml/h) of nimodipine solution will be administered continuously 1 h prior to start of operation until 1 h after start of the procedure. • The nimodipine dose will be then reduced to 2 mg/h (10 ml/h) until 24 hrs after the end of the procedure.

Nimodipine

Isotonic Saline DRUG

A continuous dose of 20 ml/h of normal saline solution will be administered continuously one (1) h prior to start of operation until 1 h after start of the procedure. The normal saline dose will be then reduced to 10 ml/h until 24 h after the end of the procedure.

Isotonic saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for open surgical treatment of bowel cancer at the General Hospital of Patra

You may not qualify if:

• Age \< 18 years, \> 75 years
• American Society of Anesthesiologists (ASA) physical status \> III
• Allergy to nimodipine
• Inability to provide informed consent
• Known severe renal insufficiency
• Known severe bradyarrhythmia
• Daily opioid consumption the last 7 days before surgery
• Pain intensity assessed using the Numerical Rating Scale (NRS; 0-10), with scores greater than 5 reported on more than half of the days during the past month.

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

St. Andrews General Hospital of Patras, GREECE

Pátrai, Achaea, 263 32, Greece

RECRUITING

MeSH Terms

Conditions

Pain; Pain, Postoperative; Acute Pain

Interventions

Nimodipine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nicotinic Acids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Petros Tzimas, MD, PhD

  University of Ioannina, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria-Theodora Filou, MD

CONTACT

00306948127570; marilizafilou@gmail.com

Ourania Patroni, MD

CONTACT

00302613601673; patronirania@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization and study medication will be handled by the hospital pharmacy. All research team members, caregiving clinicians and enrolled patients will be blinded to the study allocation arms and the randomization list will be concealed until all statistical analyses are made.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: Forty patients (20 in each arm) undergoing surgical treatment for high-risk general surgery (open colectomy) will be included in this prospective, randomized, double-blind, controlled trial with two investigation arms: intervention arm (nimodipine). control arm (isotonic saline).

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 2, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): May 19, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)