RecruitingNot ApplicableNCT07048522

Perioperative Intravenous Nimodipine Trial

Perioperative Nimodipine for Intra- and Postoperative Pain Management and Reduction of Anesthetic Requirements in Patients Undergoing Open Colectomy: a Prospective, Double-blind, Randomized Controlled Trial

Sponsor

University of Ioannina

Enrollment

40 participants

Start Date

May 19, 2025

Study Type

INTERVENTIONAL

Conditions

Colectomy Pain Pain, Postoperative Pain, Acute Open Surgery

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

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

Exclusion Criteria8

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.

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Interventions

DRUGNimodipine

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.

DRUGIsotonic Saline

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.