Perioperative Intravenous Nimodipine Trial
NCT07048522 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-07-02
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
Interventions
- DRUG
-
Nimodipine
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.
- DRUG
-
Isotonic 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.
Sponsors & Collaborators
-
University of Ioannina
lead OTHER
Principal Investigators
-
Petros Tzimas, MD, PhD · University of Ioannina, Greece
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-19
- Primary Completion
- 2026-05-19
- Completion
- 2027-02-15
Countries
- Greece
Study Locations
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