Dexmedetomidine in Thoracoscopic Surgery: Opioid-Sparing Strategy

Impact of Dexmedetomidine as an Opioid-Sparing Strategy in Thoracoscopic Surgery: A Randomised Controlled Trial

Numerous studies in recent years have shown that the use of opioid-free analgesia can reduce opioid use and length of stay in the recovery room, as published in the journals Anesthesia & Analgesia1. Compared with traditional opioid analgesic anesthesia, opioid-free analgesic anesthesia can be used to reduce postoperative respiratory complications, postoperative nausea and vomiting, and postoperative opioid needs. During surgery, opioid analgesics may have immunosuppressive effects, but different anesthesia/analgesia methods will change the individual's stress response, affect the human body's cellular immunity, and may even lead to changes in angiogenesis growth factors associated with cancer recurrence, so it is likely to affect the prognosis of cancer patients. In addition, Dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, can replace opioids for pain relief during surgery, providing superior analgesia and reducing opioid use while reducing the need for general anesthetics amount, thus avoiding suppression of immune system function. A study in the Journal of Anaesthesiology Clinical Pharmacology pointed out that Dexmedetomidine can be used to replace opioid analgesics in surgical anesthesia, and there was no difference in the use of rescue opioid analgesics during and after surgery5. Several clinical studies have shown that opioid-free anesthesia is significantly associated with a lower incidence of respiratory complications and postoperative nausea and vomiting. Therefore, general anesthesia combined with Dexmedetomidine can be regarded as an opioid-free anesthesia strategy.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Opioid Use
• Intervention / Treatment: Drug: Dexmedetomidine

Detailed Description

Study protocol

All patients received target-controlled infusion (TCI) propofol (3-5 μg ml-1), 2% lidocaine 1.5 mg kg-1 and cisatracurium (0.15-0.2 mg kg-1) or rocuronium (0.6-1.0 mg kg-1).

During induction, the dexmedetomidine group received a loading dose of 0.5 µg kg-1 of dexmedetomidine for 10 minutes. Meanwhile, propofol TCI was started with target of bispectral index set between 40 and 60. After the loading dose was complete, tracheal intubation was performed without opioid analgesic. The following maintenance dose was set as 0.5 µg kg-1 h-1 until the specimen was excised and two-lung ventilation was performed. Dexmedetomidine was then stopped. In contrast, the conventional control group was administered an intermittent bolus dose of fentanyl (0.3-0.5 µg kg-1) to reduce stimuli before tracheal intubation.

In the maintenance phase, parecoxib (40 mg) or propacetamol (1 g) was given if indicated. Anaesthesia was maintained with TCI propofol, and the depth of anaesthesia was monitored using a bispectral index between 40 and 60. Fentanyl was used as a rescue analgesic during the operation. In both groups, when the patient's HR or mean arterial pressure (MAP) was >25% of the baseline, an intermittent bolus dose of 15-25 µg fentanyl was administered. At the end of surgery, patients received intercostal nerve block under thoracoscopy by surgeon.

Haemodynamic stabilisation was achieved in the following situations. If analgesic was administered but the MAP remained elevated at >25% of baseline, nicardipine was considered. If hypotension with MAP dropped >25% from baseline, ephedrine was considered. If bradycardia with HR dropped to <50, atropine was considered.

Pain intensity was assessed in the post-anaesthesia care unit (PACU) using a numerical rating scale (NRS) ranging from 0 to 10 every 15 minutes until 1 hour after surgery. The goal NRS score was <3. If the severity was higher than 3, an intermittent bolus of fentanyl was used. Furthermore, we recorded postoperative complications including nausea, vomiting and respiratory compromise. On the following day, we visited the patient to record complications, severity of postoperative pain and analgesia use in the general ward.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung city, Taiwan
    • Kaohsiung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age older than 20 years old and younger than 75 years old
• Diagnosed as stage I-III non-small cell lung cancer
• Received video-assisted thoracoscopic lung wedge resection or lobectomy

Exclusion Criteria:

• Cardiac arrhythmia , such as sinus bradycardia, sinus tachycardia, or high-degree atrioventricular block
• Diagnosed acute myocardial myocardial infarction, congestive heart failure, or stroke within one year
• Patient have underwent coronary artery bypass graft
• Allergy to drug such as Propofol, Sevoflurane, Dexmedetomidine, NSAID, Lidocaine)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Total intravenous anesthesia (TIVA) + Dexmedetomidine; Total intravenous anesthetic drug is propofol. Dexmedetomidine is infused continuously.	Drug: Dexmedetomidine; Initially give loading dose with 0.5 mcg/kg for 10 min and then keep maintenance dose with 0.5 mcg/kg/h until two-lung ventilation.
No Intervention: Total intravenous anesthesia (TIVA); Total intravenous anesthetic drug is propofol. The ordinary pain is controlled mainly by opioids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference in the perioperative dosage of fentanyl between the two groups.	The difference in the perioperative dosage of fentanyl between the two groups.	up to post operation day one

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain scale	The pain scale will be assessed postoperatively	up to post operation day one
Perioperative hemodynamic parameters	Perioperative blood pressure and heart rate	up to post operation day one
Postoperative complications	Assessment of nausea and vomiting and respiratory compromise)	up to post operation day one

Collaborators and Investigators

• Sponsor: Kaohsiung Veterans General Hospital.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Non-small Cell Lung Cancer; Opioid-free anesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: KSVGH22-CT2-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No