Laparoscopic SurgeryPhase 2/3NCT06394375
Opioid Free Anesthesia in Abdominal Laparoscopic Surgery
A Phase 2/3 study testing Dexmedetomidine and Fentanyl in people with Laparoscopic Surgery and Abdominal Surgery, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Effectiveness of opioid free anesthesia using Dexmedetomidine to inhibit nociception in abdominal laparoscopic surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Surgery, Abdominal Surgery
- What is being tested?
- Dexmedetomidine and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2023to 31 Dec 2023
- Phase
- Phase 2/3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing abdominal laparoscopic surgery (digestive, urologic, gynecologic surgery) with general anesthesia
- BMI <= 30 kg/m2
- Assessed with ASA 1-3
- Willing to participate in this study
Who cannot join
- Allergy to dexmedetomidine
- Heart rate < 60 or systolic blood pressure <100 mmHg
- Severe cardiovascular, uncontrolled hypertension (stage 2) or hepatic or renal disorder
- Sepsis
- Pregnancy
- Difficult airway
Show all 10Show fewer
- Drop out Criteria:
- Intraoperative emergency
- Convert to open laparatomy
- Decided to withdraw from the study
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official title: Effectiveness of Opioid Free Anesthesia Using Dexmedetomidine Inhibiting Nociception in Abdominal Laparoscopic Surgery
Effectiveness of opioid free anesthesia using Dexmedetomidine to inhibit nociception in abdominal laparoscopic surgery
Read the detailed description
Abdominal laparoscopic surgery is one of the most common procedures worldwide, commonly facilitated with opioid balanced anesthesia or regional anesthesia. Despite being a controversy, there are issues that suggest opioid to have an influence in tumor recurrence. The investigators performed general anesthesia without opioid in laparoscopic abdominal surgery, and compared the hemodynamic instability, total consumption of fentanyl rescue, qNOX score, Ephedrine intraoperative, and Numerical Rating Scale.
- Conditions
- Laparoscopic Surgery, Abdominal Surgery
- Being tested
- Dexmedetomidine, Fentanyl
- Keywords
- Abdominal surgery, Laparoscopic surgery, Dexmedetomidine, Opioid free anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
OFA
FentanylDrug
Given as analgesia in opioid balanced anesthesia (control) group
| Study group | Role | What they receive |
|---|---|---|
| Opioid free anesthesia | Experimental | Patients in this group are given a combination of Dexmedetomidine, Lidocaine, Propofol, Sevoflurane, Rocuronium for induction and maintenance of general anesthesia. They are given rescue analgesia (fentanyl) when required, and Ephedrine as needed.
Patients were monitored using standard ASA monitoring and Connox.
Post operative pain score was assessed with NRS Receives: Drug: Dexmedetomidine |
| Opioid balanced anesthesia | Active comparator | Patients in this group are given a combination of Opioid (Fentanyl), Lidocaine, Propofol, Sevoflurane, Rocuronium for induction and maintenance of general anesthesia. They are given Ephedrine as needed.
Patients were monitored using standard ASA monitoring and Connox.
Post operative pain score was assessed with NRS Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
blood pressure, both systolic and diastolic measured with non invasive blood pressure monitoring
Measured: Intraoperative
Heart rate
Heart rate
Measured: Intraoperative
Secondary outcomes (4)
Total consumption of Opioid
Total consumption of fentanyl as rescue analgesia in mcg
Measured: Intraoperative
quantium nociception index (qNOX)
qNox score is measured at specific time points, available from Conox monitor measurement since the start of the procedure. Higher value indicates more nociception experienced by the patient (0-100)
Measured: Intraoperative
Ephedrine
Total consumption of ephedrine to increase heart rate and blood pressure in mg
Measured: intraoperative
Pain score
Numerical rating scale 0-10 is used to quantify pain score postoperatively, with higher value indicating more pain experienced by the patient
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Jul 2023
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into two groups for control (opioid balanced anesthesia) or intervention (opioid free anesthesia)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Rosita Tantri, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394375
- Sponsor's protocol ID
- IndonesiaU23061029
- Status last verified
- May 2024
- First submitted
- 20 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Opioid Free Anesthesia Using Dexmedetomidine Inhibiting Nociception in Abdominal Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT06394375
- Acronym / sponsor ID
- IndonesiaU23061029
- Conditions
- Laparoscopic Surgery, Abdominal Surgery
- Keywords
- Abdominal surgery, Laparoscopic surgery, Dexmedetomidine, Opioid free anesthesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 May 2024 (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.
Effectiveness of opioid free anesthesia using Dexmedetomidine to inhibit nociception in abdominal laparoscopic surgery
Detailed description
Abdominal laparoscopic surgery is one of the most common procedures worldwide, commonly facilitated with opioid balanced anesthesia or regional anesthesia. Despite being a controversy, there are issues that suggest opioid to have an influence in tumor recurrence. The investigators performed general anesthesia without opioid in laparoscopic abdominal surgery, and compared the hemodynamic instability, total consumption of fentanyl rescue, qNOX score, Ephedrine intraoperative, and Numerical Rating Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomized into two groups for control (opioid balanced anesthesia) or intervention (opioid free anesthesia)
| Arm | Type | Receives |
|---|---|---|
| Opioid free anesthesia | Experimental | Drug: DexmedetomidinePatients in this group are given a combination of Dexmedetomidine, Lidocaine, Propofol, Sevoflurane, Rocuronium for induction and maintenance of general anesthesia. They are given rescue analgesia (fentanyl) when required, and Ephedrine as needed. Patients were monitored using standard ASA monitoring and Connox. Post operative pain score was assessed with NRS |
| Opioid balanced anesthesia | Active comparator | Drug: FentanylPatients in this group are given a combination of Opioid (Fentanyl), Lidocaine, Propofol, Sevoflurane, Rocuronium for induction and maintenance of general anesthesia. They are given Ephedrine as needed. Patients were monitored using standard ASA monitoring and Connox. Post operative pain score was assessed with NRS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing abdominal laparoscopic surgery (digestive, urologic, gynecologic surgery) with general anesthesia
- BMI <= 30 kg/m2
- Assessed with ASA 1-3
- Willing to participate in this study
Key exclusion criteria (10 listed)
- Allergy to dexmedetomidine
- Heart rate < 60 or systolic blood pressure <100 mmHg
- Severe cardiovascular, uncontrolled hypertension (stage 2) or hepatic or renal disorder
- Sepsis
- Pregnancy
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 |
|---|---|---|
| DexmedetomidineOFA | Drug | Opioid free anesthesia |
| FentanylGiven as analgesia in opioid balanced anesthesia (control) group | Drug | Opioid balanced anesthesia |
Primary outcome
Blood pressure
Time frame: Intraoperative
blood pressure, both systolic and diastolic measured with non invasive blood pressure monitoring
Heart rate
Time frame: Intraoperative
Heart rate
4 secondary outcomes
Total consumption of Opioid
Time frame: Intraoperative
quantium nociception index (qNOX)
Time frame: Intraoperative
Ephedrine
Time frame: intraoperative
Pain score
Time frame: 24 hour
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 3 May 2024.
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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 Phase 2/3 study testing Dexmedetomidine and Fentanyl in people with Laparoscopic Surgery and Abdominal Surgery, run by Universitas Indonesia at 1 site in Indonesia.
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 4 inclusion and 10 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 3 May 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 Indonesia. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Blood pressure (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2024.