Dexmedetomidine + Ketamine for Postoperative Pain
Recruiting in Palo Alto (17 mi)
Overseen byVeronique Brulotte, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ciusss de L'Est de l'Île de Montréal
Must not be taking: Beta-blockers, Pregabalin, Gabapentin, others
Disqualifiers: Chronic pain, Allergy, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Postoperative pain after VATS surgery is significant and associated with moderate to high post operative morphine requirements, which can cause opioid related side effects and delay postoperative recovery. To reduce this requirement, multimodal analgesia with non opioid medication such as dexmedetomidine and ketamine can be used. These drugs have demonstrated significant opioid-sparing properties after various types of surgeries. However, very little is known about their ability to do so in VATS surgery. Also, their relative opioid-sparing properties have not been compared, and it is not known whether their combined use can lead to an additional opioid-sparing effect. The primary goal of this study will be to determine the impact of a combined intra operative infusion of ketamine and dexmedetomidine on postoperative morphine requirements in patients undergoing elective VATS, compared to both these drugs infused separately.
The hypothesis is that this combined infusion will lead to a 30% further reduction in morphine requirements, 24h after surgery, compared to both these drugs infused separately.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as beta-blockers, pregabalin, gabapentin, amitryptillin, nortryptillin, and duloxetin, before participating.
What data supports the effectiveness of the drug combination of Dexmedetomidine and Ketamine for postoperative pain?
Research shows that using dexmedetomidine and ketamine together can help reduce pain after surgery. For example, studies have found that this combination can lower the need for opioids (strong painkillers) and improve pain relief in surgeries like thoracic and femur fracture surgeries.
12345Is the combination of dexmedetomidine and ketamine generally safe for humans?
Research shows that dexmedetomidine and ketamine are often used together in medical settings, such as for pain relief after surgery, and are generally considered safe. However, they can have side effects, so their use is carefully monitored by healthcare professionals.
12367How does the drug combination of Dexmedetomidine and Ketamine differ from other pain management options?
The combination of Dexmedetomidine and Ketamine for postoperative pain is unique because it leverages the calming effects of Dexmedetomidine and the pain-relieving properties of Ketamine, potentially reducing the need for opioids and their associated side effects. This combination can enhance pain relief and extend the duration of analgesia compared to using either drug alone or standard pain management options.
148910Eligibility Criteria
This trial is for adults aged 18-80 undergoing elective lung surgery (VATS) who are generally healthy or have mild to moderate systemic disease. It's not for those planning to use regional anesthesia post-surgery, on certain pain medications like beta-blockers or chronic pain treatments, with allergies to the study drugs, pregnant, unable to consent, or facing language barriers.Inclusion Criteria
My health is good to moderately impaired according to anesthesia standards.
I am between 18 and 80 years old.
I am scheduled for a lung surgery using a camera-assisted method.
Exclusion Criteria
You are allergic to ketamine or dexmedetomidine.
I take more than 60 mg of morphine daily for chronic pain.
Pregnancy
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Intraoperative infusion of ketamine and dexmedetomidine to reduce postoperative morphine requirements
Intraoperative
1 visit (in-person)
Postoperative Monitoring
Monitoring of postoperative morphine requirements and pain scores at rest and after coughing
48 hours
Continuous monitoring
Follow-up
Participants are monitored for persistent postoperative pain and other outcomes
3 months
Participant Groups
The study tests if combining two non-opioid drugs—dexmedetomidine and ketamine—during surgery can better reduce the need for morphine afterward compared to using each drug alone. The goal is a further 30% reduction in morphine use after VATS when both drugs are infused together.
3Treatment groups
Active Control
Group I: Ketamine hydrochlorideActive Control1 Intervention
Intraoperative bolus (0.25 mg/kg) and infusion (0.25mg/kg/h) of ketamine plus an intraoperative bolus (over 20 min) and infusion of normal saline;
Group II: dexmedetomidine hydrochlorideActive Control1 Intervention
Intraoperative bolus (1µg/kg over 20 min) and infusion (0.5µg/kg/h) of dexmedetomidine plus an intraoperative bolus and infusion of normal saline
Group III: dexmedetomidine hydrochloride and ketamine hydrochlorideActive Control1 Intervention
Intraoperative bolus (1µg/kg over 20 min) and infusion (0.5 µg/g/h) of dexmedetomidine plus an intraoperative bolus (0.25mg/kg) and infusion (0.25mg/kg/h) of ketamine
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
CiusssMontréal, Canada
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Who Is Running the Clinical Trial?
Ciusss de L'Est de l'Île de MontréalLead Sponsor
References
Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial. [2023]Patients often experience severe pain after scoliosis correction surgery. Esketamine and dexmedetomidine each improves analgesia but can produce side-effects. We therefore tested the hypothesis that a mini-dose esketamine-dexmedetomidine combination safely improves analgesia.
Intraoperative Dexmedetomidine and Ketamine Infusions in an Enhanced Recovery After Thoracic Surgery Program: A Propensity Score Matched Analysis. [2022]To assess the impact of intraoperative dexmedetomidine and ketamine on postoperative pain and opioid consumption within an ERAS program in thoracic pulmonary oncologic surgery.
Effect of local wound infiltration with ketamine versus dexmedetomidine on postoperative pain and stress after abdominal hysterectomy, a randomized trial. [2019]Postoperative pain and stress elicit hormonal changes. We aimed at comparing the effects of wound infiltration with ketamine versus dexmedetomidine on postoperative pain and stress response.
Efficacy of dexmedetomidine and ketamine addition to bupivacaine 0.25% by epidural method in reducing postoperative pain in patients undergoing femur fracture surgery. [2022]One of the most complex medical problems is pain, that due to inappropriate management of patients after surgery could cause various side effects on the psychological, physiological, and metabolic state of the patients. The natural duration of analgesia can be increased by adding new efficient adjuvant. The present study is mainly aimed to investigate the differences between the epidural dexmedetomidine and ketamine effectiveness when administered as an adjuvant to epidural 0.25% bupivacaine for improving the postoperative analgesia duration.
Peri-operative ketamine for acute post-operative pain: a quantitative and qualitative systematic review (Cochrane review). [2022]Post-operative pain management is usually limited by adverse effects such as nausea and vomiting. Adjuvant treatment with an inexpensive opioid-sparing drug such as ketamine may be of value in giving better analgesia with fewer adverse effects. The objective of this systematic review was to evaluate the effectiveness and tolerability of ketamine administered peri-operatively in the treatment of acute post-operative pain in adults.
Comparison of the effects of dexmedetomidine and propofol in reducing recovery agitation in pediatric patients after ketamine procedural sedation in emergency department. [2022]Ketamine has been a safe and effective sedative agent commonly used for painful pediatric procedures in the emergency department (ED). This study aimed to compare the effect of dexmedetomidine (Dex) and propofol when used as co-administration with ketamine on recovery agitation in children who underwent procedural sedation.
Dexmedetomidine provides neuroprotection: impact on ketamine-induced neuroapoptosis in the developing rat brain. [2022]Ketamine and dexmedetomidine are increasingly used in combination in pediatric patients. This study examined the hypothesis that dexmedetomidine attenuated ketamine-induced neurotoxicity.
Comparison of intradermal Dexmedmotidine and subcutaneous Ketamine for post-surgical pain management in patients with abdominal hysterectomy. [2020]Hysterectomy after cesarean section is the second most commonly used surgery for women in the United States. One of the most common problem after hysterectomy is pain. We decided to compare the effects of dexmedmotidine or ketamine on pain in patients by a double blind randomized clinical trial on 126 female candidates for abdominal hysterectomy in three groups of 42 persons referred to Taleghani hospital in Arak. For the first group, 50 micrograms of intradermal dexmedmotidine were injected, while in the second group, patients were injected with 100 mg of subcutaneous ketamine and the third group received 5 cc normal saline. Data were next analyzed by SPSS version 19. The mean age and body mass index of the patients were not significantly different in the three groups. The mean scores of pain during recovery of patients in ketamine, dexmedmotidine and placebo groups were 4.2±0.77, 2.6±0.89 and 1.3±0.87, respectively (p = 0.001). Scores of pain in patients at 4 and 8 hours after surgery showed also significant differences. In conclusion, ketamine and dexmedmotidine significantly reduce the severity of pain, but ketamine has a lower effect.
Dexmedetomidine-ketamine versus Dexmedetomidine-midazolam-fentanyl for monitored anesthesia care during chemoport insertion: a Prospective Randomized Study. [2022]Dexmedetomidine as a sole agent showed limited use for painful procedures due to its insufficient sedative/analgesic effect, pronounced hemodynamic instability and prolonged recovery. The aim of this study was to compare the effects of dexmedetomidine-ketamine (DK) versus dexmedetomidine-midazolam-fentanyl (DMF) combination on the quality of sedation/analgesia and recovery profiles for monitored anesthesia care (MAC).
Comparison of the Effect of Ketamine and Dexmedetomidine Combined with Total Intravenous Anesthesia in Laparoscopic Cholecystectomy Procedures: A Prospective Randomized Controlled Study. [2022]This randomized prospective clinical study aimed to investigate the effects of dexmedetomidine or ketamine administration to total intravenous anesthesia (TIVA) on postoperative analgesia in subjects undergoing elective laparoscopic cholecystectomy procedures. 90 adults, American Society of Anesthesiologists (ASA) physical status 1 and II patients, who underwent elective laparoscopic cholecystectomy procedures were included in the study and randomized into three groups equally. Remifentanil, propofol, and rocuronium infusions were used for TIVA guided by the bispectral index. In group KETA, 10 μg/kg/min ketamine was added to TIVA before surgery, and in group DEX, 0.5 μg/kg/h dexmedetomidine was added to TIVA before surgery. Normal saline infusions were infused in the control group. Postoperative analgesia was provided with intravenous patient-controlled analgesia (PCA) morphine (1 mg bolus morphine, 5 min lockout time). Hemodynamic parameters, scores of visual analogue scale (VAS) for pain, rescue morphine requirements, and side effects such as sedation, nausea, and vomiting were recorded for 48 hours after surgery. Postoperative first analgesic requirement time was longer in group KETA (P < 0.001), and it was longer in group DEX than in the control group (P < 0.001). Pain scores were lower in group KETA and group DEX than in the control group at all corresponding times throughout the 48 h period of observation. Intravenous PCA morphine consumptions were higher in the control group than in group KETA (P < 0.001 for all followed-up times), and they were higher in group DEX than in group KETA (P < 0.001 for all followed-up times). It is concluded that the use of dexmedetomidine or ketamine infusions can be suitable as an additive for TIVA in the intraoperative period. Furthermore, the addition of both drugs to the TIVA protocol may improve postoperative pain relief and decrease opioid consumption.