Dexmedetomidine for Laparoscopic Abdominal Surgery

(DEXREM Trial)

Not yet recruiting at 1 trial location

Overseen By Nadia Godin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ciusss de L'Est de l'Île de Montréal

Must not be taking: Opioids

Disqualifiers: Pregnancy, Breastfeeding, Bradycardia, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Intraoperative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether dexmedetomidine, a medication that calms and relieves pain, can reduce the need for opioids during and after laparoscopic abdominal surgery. Opioids are powerful painkillers but can cause unpleasant side effects, making alternatives important. Participants will receive either dexmedetomidine or a placebo (a harmless substance with no active drug) to determine its effect on reducing opioid use. This trial suits those undergoing laparoscopic surgeries, such as general, gynecological, or urological procedures, who are not chronic opioid users and have no allergies to the trial's medications. As an unphased trial, this study provides a unique opportunity to contribute to research that could lead to safer pain management options.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using opioids regularly, you cannot participate in this trial.

Is there any evidence suggesting that dexmedetomidine is likely to be safe for humans?

Research has shown that dexmedetomidine is generally safe for use during surgery. Studies have found that it can reduce nausea and vomiting post-surgery and speed up digestive system recovery. It may also enhance kidney function and improve overall patient recovery. Notably, dexmedetomidine can decrease the need for other pain medications, resulting in fewer side effects from those drugs.

While these studies highlight positive outcomes, every medication can have side effects. So far, dexmedetomidine appears well-tolerated by most patients. Prospective clinical trial participants should discuss potential risks with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Dexmedetomidine is unique because it provides sedation with analgesic properties during laparoscopic abdominal surgery, potentially enhancing patient comfort and recovery. Unlike standard anesthetics that often focus solely on sedation or pain relief, dexmedetomidine works by engaging alpha-2 adrenergic receptors, which can offer both calming effects and pain control. Researchers are excited about its ability to reduce the need for additional pain medications and its potential to improve the overall anesthesia experience, minimizing side effects like nausea and prolonged sedation that are common with traditional options.

What evidence suggests that dexmedetomidine might be an effective treatment for reducing opioid consumption during laparoscopic abdominal surgery?

Research has shown that dexmedetomidine, which participants in this trial may receive, can reduce the need for painkillers like morphine after surgery. One study found that patients who received dexmedetomidine during surgery required less morphine afterward. Another study demonstrated that dexmedetomidine improved recovery and reduced long-term pain post-surgery. For certain abdominal surgeries, dexmedetomidine was associated with reduced use of painkillers during the operation. It also lowered the chances of nausea or vomiting after surgery. Overall, these findings suggest that dexmedetomidine could be a promising option for managing pain with fewer side effects from painkillers. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing elective laparoscopic abdominal surgery who may benefit from an opioid-sparing pain management strategy. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that would exclude them.

Inclusion Criteria

I had laparoscopic surgery with a small cut (less than 5 cm).

My health is good to moderately impaired.

Exclusion Criteria

Pregnant or breastfeeding women

Chronic use of opioids

Allergy to medication used in the trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either dexmedetomidine or placebo during laparoscopic abdominal elective surgery to assess intraoperative remifentanil consumption

Intraoperative period

1 visit (in-person)

Post-Anesthesia Care Unit (PACU)

Participants are monitored for pain scores, morphine equivalent consumption, and adverse events in the PACU

From PACU admission to discharge

Follow-up

Participants are monitored for pain scores and quality of recovery 24 hours post-operation

24 hours post-op

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine

Trial Overview

The study is testing whether dexmedetomidine can reduce the need for remifentanil, a common opioid used during surgery. Participants will be randomly assigned to receive either dexmedetomidine or a placebo in addition to standard care.

How Is the Trial Designed?

Group I: Dexmedetomidine Active Control 1 Intervention

Dexmedetomidine 0.5 mcg/kg (adjusted body weight) ; Administered via infusion pump (Smith Medical Medfusion® 4000 Syringe Infusion Pump) delivered over 10 minutes during induction of general anesthesia, followed by dexmedetomidine 0.5 mcg.kg-1.h-1 (maximum dose: 2.5mcg.kg-1)

Group II: Placebo - Normal Saline Placebo Group 1 Intervention

Normal saline in volume equivalent of dexmedetomidine dose according to patient weight ; Administered via infusion pump (Smith Medical Medfusion® 4000 Syringe Infusion Pump) so that the full dose is delivered is equivalent to a maximum dose of 2.5mcg.kg-1 of dexemedetomidine

Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in United States as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Canada as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Japan as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Published Research Related to This Trial

Dexmedetomidine is commonly used as a safe sedative during surgeries, but there are rare cases where it can lead to serious complications, such as cardiac arrest.

In this report, a 76-year-old woman experienced cardiac arrest during a pacemaker lead extraction procedure while being treated with dexmedetomidine, highlighting the need for careful monitoring in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. Shah, AN., Koneru, J., Nicoara, A., et al.[2013]

Dexmedetomidine (DEX) is an effective sedative that provides anxiolysis and sedation without causing respiratory depression, making it suitable for use in pediatric intensive care.

In a case involving a three-year-old girl with a pacemaker, DEX administration led to unsuccessful atrial capture, suggesting that caution is needed when using DEX in patients with existing conduction abnormalities or those who are pacemaker-dependent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine-related atrial standstill and loss of capture in a pediatric patient after congenital heart surgery. Shepard, SM., Tejman-Yarden, S., Khanna, S., et al.[2013]

In a study of 30 patients with liver dysfunction undergoing percutaneous arterial chemoembolization for hepatocellular carcinoma, dexmedetomidine sedation was successfully used in all cases, demonstrating its feasibility for this procedure.

The sedation was generally safe, with only minor adverse events reported in 3 patients, and no serious complications requiring treatment, indicating that dexmedetomidine can be a reliable option for sedation in patients with liver issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Feasibility and Safety of Dexmedetomidine Sedation in Transarterial Embolization for Hepatocellular Carcinoma with Hepatitis C-Related Cirrhosis]. Komemushi, A., Suzuki, S., Sano, A., et al.[2015]

In a study involving 91 pediatric patients, dexmedetomidine was found to be a well-tolerated alternative sedative for non-intubated moderate or deep sedation, with a low incidence of serious adverse events.

While respiratory depression and hypotension were the most common treatment-emergent adverse events, they were manageable and consistent with dexmedetomidine's known safety profile, indicating its potential for safe use in children during elective procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. Jooste, EH., Hammer, GB., Reyes, CR., et al.[2020]

Dexmedetomidine is an alpha-2 adrenergic agonist that provides sedation and pain relief without causing respiratory depression, making it a safe option for patients requiring sedation.

In a case study, dexmedetomidine was effectively used as an adjuvant analgesic for a patient with cancer pain that did not respond to other treatments, highlighting its potential role in managing complex pain scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine as an adjuvant analgesic for intractable cancer pain. Roberts, SB., Wozencraft, CP., Coyne, PJ., et al.[2013]

In a study of 73 patients undergoing laparoscopic bariatric surgery, those who received dexmedetomidine experienced a significant reduction in narcotic use (66 mg vs 130 mg of morphine equivalents) and were more likely to meet discharge criteria on the first postoperative day (61% vs 26%).

Dexmedetomidine was found to be safe and effective in minimizing narcotic requirements and potentially reducing hospital stay duration, which is particularly beneficial for patients with a high risk of respiratory complications, such as those with obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of perioperative dexmedetomidine infusion on postoperative narcotic use and duration of stay after laparoscopic bariatric surgery. Dholakia, C., Beverstein, G., Garren, M., et al.[2018]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11305718/

Effectiveness of different doses of dexmedetomidine on ...

Continuous intravenous administration of dexmedetomidine during abdominal surgery has been shown to effectively reduce postoperative morphine requirements and ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0007091224003465

Effectiveness of dexmedetomidine on patient-centred ...

Intraoperative dexmedetomidine likely results in meaningful improvement in the quality of recovery and chronic pain after surgery.

3.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2784993

Effect of Intraoperative Dexmedetomidine on Recovery ...

The use of intraoperative dexmedetomidine was associated with improved kidney function in one study and higher urine output among patients in ...

4.

academic.oup.com

academic.oup.com/qjmed/article/117/Supplement_2/hcae175.048/7903966

Using a Dexmedetomidine as an Opiates Reducing Agent in ...

In patients undergoing laparoscopic abdominal surgeries, dexmedetomidine infusion was associated with significantly less intraoperative and ...

5.

bmcanesthesiol.biomedcentral.com

bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-024-02868-0

Effect of perioperative dexmedetomidine on recovery of ...

However, dexmedetomidine administration was associated with a decreased incidence of postoperative nausea and vomiting (RR = 0.72, 95% CI = 0.58 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9791264/

Efficacy and safety evaluation of dexmedetomidine for ...

The results show that the use of DEX for PCIA can significantly reduce the incidence of postoperative nausea and vomiting, compared with PCIA ...

7.

wjgnet.com

wjgnet.com/1007-9327/full/v31/i31/110582.htm

Efficacy and safety of different doses of dexmedetomidine ...

Both low- and high-dose dexmedetomidine regimens enhance postoperative gastrointestinal recovery after laparoscopic colorectal surgery. The low- ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7223065/

Dexmedetomidine in Enhanced Recovery After Surgery ...

It demonstrated improved pain scores, delayed rescue analgesia, and decreased total rescue analgesic dose [59].