Opioid UseNCT05431322
Dexmedetomidine in Thoracoscopic Surgery: Opioid-Sparing Strategy
A study testing Dexmedetomidine in people with Opioid Use and Postoperative Pain, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Opioid Use, Postoperative Pain
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Use, Postoperative Pain
- Being tested
- Dexmedetomidine
- Keywords
- Dexmedetomidine, Opioid-free anesthesia, Non-small Cell Lung Cancer
- Medical subject headings
- Pain, Postoperative, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Total intravenous anesthesia (TIVA) + Dexmedetomidine | Experimental | Total intravenous anesthetic drug is propofol. Dexmedetomidine is infused continuously. Receives: Drug: Dexmedetomidine |
| Total intravenous anesthesia (TIVA) | No intervention | Total intravenous anesthetic drug is propofol. The ordinary pain is controlled mainly by opioids. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the perioperative dosage of fentanyl between the two groups.
The difference in the perioperative dosage of fentanyl between the two groups.
Measured: up to post operation day one
Secondary outcomes (3)
Postoperative pain scale
The pain scale will be assessed postoperatively
Measured: up to post operation day one
Perioperative hemodynamic parameters
Perioperative blood pressure and heart rate
Measured: up to post operation day one
Postoperative complications
Assessment of nausea and vomiting and respiratory compromise)
Measured: up to post operation day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jun 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Wei Hsieh, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431322
- Sponsor's protocol ID
- KSVGH22-CT2-20
- Status last verified
- Jan 2024
- First submitted
- 14 Jun 2022
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hsieh KW, Wen CH, Chen CH. Dexmedetomidine-based opioid-sparing anesthesia in video-assisted thoracoscopic surgery: a randomized controlled trial. BMC Anesthesiol. 2026 Jul 24;26(1):632. doi: 10.1186/s12871-026-04070-w.
PubMed 42897486
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dexmedetomidine as an Opioid-Sparing Strategy in Thoracoscopic Surgery: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05431322
- Acronym / sponsor ID
- KSVGH22-CT2-20
- Conditions
- Opioid Use, Postoperative Pain
- Keywords
- Dexmedetomidine, Opioid-free anesthesia, Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 24 Jun 2022 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia (TIVA) + Dexmedetomidine | Experimental | Drug: DexmedetomidineTotal intravenous anesthetic drug is propofol. Dexmedetomidine is infused continuously. |
| Total intravenous anesthesia (TIVA) | No intervention | –Total intravenous anesthetic drug is propofol. The ordinary pain is controlled mainly by opioids. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| DexmedetomidineInitially 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. | Drug | Total intravenous anesthesia (TIVA) + Dexmedetomidine |
Primary outcome
The difference in the perioperative dosage of fentanyl between the two groups.
Time frame: up to post operation day one
The difference in the perioperative dosage of fentanyl between the two groups.
3 secondary outcomes
Postoperative pain scale
Time frame: up to post operation day one
Perioperative hemodynamic parameters
Time frame: up to post operation day one
Postoperative complications
Time frame: up to post operation day one
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Derived from this study: PubMed 42897486Hsieh KW, Wen CH, Chen CH. Dexmedetomidine-based opioid-sparing anesthesia in video-assisted thoracoscopic surgery: a randomized controlled trial. BMC Anesthesiol. 2026 Jul 24;26(1):632. doi: 10.1186/s12871-026-04070-w.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Opioid Use and Postoperative Pain, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 29 Jan 2024. 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 Taiwan. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the perioperative dosage of fentanyl between the two groups. (time frame: up to post operation day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05431322, which also lists 1 linked publication.
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 29 Jan 2024.