Dexmedetomidine for Laparoscopic Abdominal Surgery

(DEXREM Trial)

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

72 Participants Needed

Trial Summary

What is the purpose of this trial?

Opioids analgesic are the gold standard for intraoperative pain management. Their short- and long-term adverse effect motivate anesthesiologists to explore opioid sparing strategies. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that could help minimize opioid consumption both intraoperative and postoperative due to its sedative, analgesic and sympatholytic properties. This new randomized controlled trial (RCT) will answer the question whether an intraoperative dexmedetomidine infusion compared to placebo has a clinically significant impact on intraoperative remifentanil consumption during a laparoscopic abdominal elective surgery.

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.

What data supports the effectiveness of the drug Dexmedetomidine for laparoscopic abdominal surgery?

Research shows that Dexmedetomidine can reduce the need for narcotics and shorten hospital stays after laparoscopic bariatric surgery, which suggests it may be effective in managing pain and recovery in similar surgical procedures. ^{1 2 3 4 5}

Is dexmedetomidine safe for use in humans?

Dexmedetomidine (also known as Precedex) is generally considered safe for use as a sedative in surgical procedures, but it can cause side effects like low blood pressure and slow heart rate. In rare cases, it has been associated with serious heart issues, especially in patients with existing heart conditions. It is important to use it carefully in patients with liver problems due to slower metabolism. ^{2 3 4 5 6}

How is the drug Dexmedetomidine unique for laparoscopic abdominal surgery?

Dexmedetomidine is unique because it provides sedation and pain relief without causing breathing problems, which is important during surgery. It also helps reduce the need for narcotics and can shorten hospital stays after surgery, making it a safer option for patients with conditions like sleep apnea. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The impact of perioperative dexmedetomidine infusion on postoperative narcotic use and duration of stay after laparoscopic bariatric surgery. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine as an adjuvant analgesic for intractable cancer pain. [2013]

3. Japan pubmed.ncbi.nlm.nih.gov

[Feasibility and Safety of Dexmedetomidine Sedation in Transarterial Embolization for Hepatocellular Carcinoma with Hepatitis C-Related Cirrhosis]. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine-related atrial standstill and loss of capture in a pediatric patient after congenital heart surgery. [2013]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. [2020]