ColectomyNCT07048522
Perioperative Intravenous Nimodipine Trial
A study testing Nimodipine and Isotonic Saline in people with Colectomy and Open Surgery, run by University of Ioannina at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colectomy, Open Surgery, Pain
- What is being tested?
- Nimodipine and Isotonic Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 19 May 2025to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for open surgical treatment of bowel cancer at the General Hospital of Patra
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
St. Andrews General Hospital of Patras, GREECE
Pátrai, Achaea, 263 32
Maria-Theodora Filou, MD, 0306948127570, marilizafilou@gmail.com
Ourania Patroni, MD, 00302613601673, patronirania@gmail.com
About this study
Official title: 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
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.
Read the detailed description
Background with aim: Acute postoperative pain is still of major clinical concern for a large number of patients undergoing surgery worldwide. Despite advances in pain management strategies, many patients continue to suffer from moderate-to-severe pain during the early postoperative period, while opioids are still largely over-prescribed. Not effectively and especially unrelieved pain can result in decreased patient satisfaction, increased morbidity, prolonged hospital length-of-stay and increased risk of persistent pain. Furthermore, effective treatment of acute postoperative pain using opioid analgesics remains the core treatment for postoperative pain. Although the potential benefits of opioid therapy for acute pain lead to a short-term pain control there are several potential severe side-effects associated with opioid use which may outweigh the benefits including sedation, nausea, vomiting, constipation especially in bowel surgery, and the risk of long-term use. Although various non-opioid drugs have been investigated over the past decades, information regarding L-type calcium channel blockers in acute postoperative pain is limited. In this respect, the perioperative use of nimodipine, a drug which furthermore crosses the blood-brain barrier and has direct effects on the Central Nernous System (CNS) could potentiate the effects of opioid analgesia and intraoperative anesthetic requirements, providing improved analgesia and potentially reduce for opioids in the perioperative period. Therefore, the investigators decided to carry out the present study with the aim to examine the analgesic efficacy and safety of perioperatively administered IV nimodipine in patients undergoing open colectomy on perioperative opioid and anesthetic consumption, pain intensity, opioid-related side effects and early postoperative bowel mobility.
Method: A power analysis based on a previous preliminary study using IV nimodipine for medium risk general surgery (open cholecystectomy) showed that 9 patients would provide a power greater than 0.9 (α = 0.05) for detection of differences of pain scores and cumulative opioid consumption over time (up to 48 h). Therefore, 40 patients undergoing open colectomy will be included in this prospective, randomized, double-blind, controlled trial with two arms: an intervention arm (IV nimodipine 2 mg/h [10 ml/h] starting 1 h prior to surgery and continuing until 24 h after the end of the procedure) and a control arm (isotonic saline 10 ml/h starting 1 h prior to surgery and continuing until 24 h after the end of the procedure). The study is approved by the local hospital scientific board (#18-4_2024-12-05).
Hypothesis: The investigators hypothesize that perioperative intravenous administration of nimodipine, an L-type calcium channel antagonist, will be effective in reducing intraoperative anesthetic requirements, as well as intra- and postoperative opioid requirements, as well as postoperative pain intensity and opioid-related side effects.
- Conditions
- Colectomy, Open Surgery, Pain, Pain, Postoperative, Pain, Acute
- Being tested
- Nimodipine, Isotonic Saline
- Medical subject headings
- Pain, Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimodipineDrug
A 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 SalineDrug
A 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Isotonic Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.
Secondary outcomes (7)
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.
Measured: From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.
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.
Measured: From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.
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).
Measured: From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.
Opioid related pruritus
Number of participants with documented pruritus related to opioid use, recorded as a binary outcome variable (yes/no).
Measured: From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.
Postoperative nausea and/or vomiting (PONV)
Number of participants with documented postoperative episodes of nausea and/or vomiting, recorded as a binary outcome variable (yes/no).
Measured: From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.
Time to first signs of bowel mobilization
Time (in hours) from the end of surgery to the first documented sign of bowel function, defined as either the first bowel sounds on auscultation or the first passage of flatus. Assessment will take place in the surgical ward at the following postoperative time points: 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, and 90 hours, or until hospital discharge, whichever comes first.
Measured: From end of surgery to 90 hours postoperatively or until hospital discharge, whichever comes first.
Length of stay (LOS)
Total duration of hospitalization, measured in days from admission to discharge.
Measured: Duration of hospitalization, from the day of admission to the day of discharge (up to 30 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start19 May 2025
- Primary completion19 Dec 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petros Tzimas, University of Ioannina
- Investigators
- Petros Tzimas, MD, PhD, Principal investigator, University of Ioannina, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048522
- Sponsor's protocol ID
- 18-4_2024-12-05
- Status last verified
- Sep 2026
- First submitted
- 20 Jun 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared upon reasonable request by other researchers
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07048522
- Acronym / sponsor ID
- 18-4_2024-12-05
- Conditions
- Colectomy, Open Surgery, Pain, Pain, Postoperative, Pain, Acute
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 19 Dec 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background with aim: Acute postoperative pain is still of major clinical concern for a large number of patients undergoing surgery worldwide. Despite advances in pain management strategies, many patients continue to suffer from moderate-to-severe pain during the early postoperative period, while opioids are still largely over-prescribed. Not effectively and especially unrelieved pain can result in decreased patient satisfaction, increased morbidity, prolonged hospital length-of-stay and increased risk of persistent pain. Furthermore, effective treatment of acute postoperative pain using opioid analgesics remains the core treatment for postoperative pain. Although the potential benefits of opioid therapy for acute pain lead to a short-term pain control there are several potential severe side-effects associated with opioid use which may outweigh the benefits including sedation, nausea, vomiting, constipation especially in bowel surgery, and the risk of long-term use. Although various non-opioid drugs have been investigated over the past decades, information regarding L-type calcium channel blockers in acute postoperative pain is limited. In this respect, the perioperative use of nimodipine, a drug which furthermore crosses the blood-brain barrier and has direct effects on the Central Nernous System (CNS) could potentiate the effects of opioid analgesia and intraoperative anesthetic requirements, providing improved analgesia and potentially reduce for opioids in the perioperative period. Therefore, the investigators decided to carry out the present study with the aim to examine the analgesic efficacy and safety of perioperatively administered IV nimodipine in patients undergoing open colectomy on perioperative opioid and anesthetic consumption, pain intensity, opioid-related side effects and early postoperative bowel mobility.
Method: A power analysis based on a previous preliminary study using IV nimodipine for medium risk general surgery (open cholecystectomy) showed that 9 patients would provide a power greater than 0.9 (α = 0.05) for detection of differences of pain scores and cumulative opioid consumption over time (up to 48 h). Therefore, 40 patients undergoing open colectomy will be included in this prospective, randomized, double-blind, controlled trial with two arms: an intervention arm (IV nimodipine 2 mg/h [10 ml/h] starting 1 h prior to surgery and continuing until 24 h after the end of the procedure) and a control arm (isotonic saline 10 ml/h starting 1 h prior to surgery and continuing until 24 h after the end of the procedure). The study is approved by the local hospital scientific board (#18-4_2024-12-05).
Hypothesis: The investigators hypothesize that perioperative intravenous administration of nimodipine, an L-type calcium channel antagonist, will be effective in reducing intraoperative anesthetic requirements, as well as intra- and postoperative opioid requirements, as well as postoperative pain intensity and opioid-related side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Nimodipine | Experimental | Drug: NimodipinePrepared (coded) by the pharmacy 50 ml solutions of nimodipine (2 mg/10 ml) with blinded 50 ml syringes will be used in each patient. |
| Isotonic saline | Placebo comparator | Drug: Isotonic SalinePrepared (coded) by the pharmacy 50 ml solutions with blinded 50 ml syringes of isotonic saline will be used in each patient. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for open surgical treatment of bowel cancer at the General Hospital of Patra
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NimodipineA 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. | Drug | Nimodipine |
| Isotonic SalineA 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. | Drug | Isotonic saline |
Primary outcome
Intraoperative Remifentanil Consumption
Time frame: Intraoperative period, defined as the time (in minutes) from induction of general anesthesia to extubation.
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 propofol consumption
Time frame: Intraoperative period, defined as the time (in minutes) from induction of general anesthesia to extubation.
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.
Cumulative opioid consumption within 0 to 72 hours postoperatively
Time frame: From Post Anesthesia Care Unit (PACU) admission (time zero) 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.
7 secondary outcomes
Pain intensity at rest
Time frame: From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.
Pain intensity during coughing
Time frame: From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.
Opioid related sedation
Time frame: From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.
Opioid related pruritus
Time frame: From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.
Postoperative nausea and/or vomiting (PONV)
Time frame: From Post Anesthesia Care Unit (PACU) admission (time zero) to 72 hours postoperatively.
Time to first signs of bowel mobilization
Time frame: From end of surgery to 90 hours postoperatively or until hospital discharge, whichever comes first.
Length of stay (LOS)
Time frame: Duration of hospitalization, from the day of admission to the day of discharge (up to 30 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. The data will be shared upon reasonable request by other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petros Tzimas, MD, PhD principal investigator
University of Ioannina, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nimodipine and Isotonic Saline in people with Colectomy and Open Surgery, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria-Theodora Filou, MD (00306948127570, marilizafilou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Remifentanil Consumption (time frame: Intraoperative period, defined as the time (in minutes) from induction of general anesthesia to extubation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.