Postoperative PainPhase 3Dex/Lido/FentNCT07350668
Opioid-Free vs Opioid-Based Anesthesia for Nasal Surgeries
A Phase 3 study testing dexmedetomidine and lignocaine infusion and Fentanyl infusion in people with Postoperative Pain, run by Benha University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate and compare the efficacy, onset, duration of action, analgesic effect, and side effects of opioid-free anesthesia using dexmedetomidine and lignocaine versus conventional opioid-based anesthesia using fentanyl in patients undergoing nasal surgeries, including functional… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- dexmedetomidine and lignocaine infusion and Fentanyl infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jan 2026
- Phase
- Phase 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between the ages of 18 and 60, scheduled to undergo elective nasal surgeries.
- ASA (American Society of Anesthesiologists) physical status I-II.
- Patients who provide written informed consent to participate in the study.
Who cannot join
- ASA III or above.
- Patients with a history of opioid dependence or chronic pain conditions requiring long-term opioid therapy.
- Patients with multiorgan failure, unstable hemodynamics prior to surgery, or scheduled for emergency surgery.
- Pregnant or lactating women.
- Patients with a history of severe asthma or those taking preoperative alpha-blockers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Opioid-Free Anesthesia vs Conventional Opioid-Based Anesthesia for Nasal Surgeries
The goal of this clinical trial is to evaluate and compare the efficacy, onset, duration of action, analgesic effect, and side effects of opioid-free anesthesia using dexmedetomidine and lignocaine versus conventional opioid-based anesthesia using fentanyl in patients undergoing nasal surgeries, including functional endoscopic sinus surgery (FESS) and septoplasty. The main questions it aims to answer are:
- What is the effect of opioid-free anesthesia vs opioid-based anesthesia on VAS score ?
- What is the effect of opioid-free anesthesia vs opioid-based anesthesia on postoperative complications including nausea and vomiting , postoperative Ramsay sedation score, amount of rescue analgesia , hemodynamic stability and patient satisfaction ? patients will be divided into two equal groups:
- Group OBA (Opioid-Based Anesthesia): Consisting of 30 participants, this group will receive intravenous fentanyl at a dose of 2 mcg.kg-1 three minutes prior to induction, followed by a fentanyl infusion at 0.5 mcg.kg-¹.h-¹ during the intraoperative period.
- Group OFA (Opioid-Free Anesthesia): Comprising 30 participants, this group will receive dexmedetomidine at a dose of 1 mcg.kg-1 via intravenous infusion over 10 minutes prior to induction, followed by a continuous infusion of 0.6 mcg.kg-¹.h-¹ throughout the surgery. Intravenous lignocaine at 1.5 mg.kg-1 will be administered three minutes prior to induction, followed by an intraoperative infusion at 1.5 mg.kg-¹.h-¹.
- Conditions
- Postoperative Pain
- Being tested
- dexmedetomidine and lignocaine infusion, Fentanyl infusion
- Keywords
- Opioid-free anesthesia, Opioid-based anesthesia, Opioid Sparing
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine and lignocaine infusionDrug
this group will receive dexmedetomidine at a dose of 1 mcg.kg-1 via intravenous infusion over 10 minutes prior to induction, followed by a continuous infusion of 0.6 mcg.kg-¹.h-¹ throughout the surgery. Intravenous lignocaine at 1.5 mg.kg-1 will be administered three minutes prior to induction, followed by an intraoperative infusion at 1.5 mg.kg-¹.h-¹.
Fentanyl infusionDrug
this group will receive intravenous fentanyl at a dose of 2 mcg.kg-1 three minutes prior to induction, followed by a fentanyl infusion at 0.5 mcg.kg-¹.h-¹ during the intraoperative period.
| Study group | Role | What they receive |
|---|---|---|
| dex and lido | Active comparator | this group will receive dexmedetomidine at a dose of 1 mcg.kg-1 via intravenous infusion over 10 minutes prior to induction, followed by a continuous infusion of 0.6 mcg.kg-¹.h-¹ throughout the surgery. Intravenous lignocaine at 1.5 mg.kg-1 will be administered three minutes prior to induction, followed by an intraoperative infusion at 1.5 mg.kg-¹.h-¹. Receives: Drug: dexmedetomidine and lignocaine infusion |
| Fent | Active comparator | this group will receive intravenous fentanyl at a dose of 2 mcg.kg-1 three minutes prior to induction, followed by a fentanyl infusion at 0.5 mcg.kg-¹.h-¹ during the intraoperative period. Receives: Drug: Fentanyl infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Visual Analog Scale for Pain (VAS), which ranges from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.
Baseline pain score will be defined as the VAS score measured immediately after arrival to the post-anesthesia care unit (PACU). The primary outcome will be the change from baseline in VAS pain scores at each postoperative assessment time point, comparing opioid-free and opioid-based anesthesia approaches
Measured: 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperatively.
Secondary outcomes (7)
Change From Baseline in Mean Arterial Pressure
Mean arterial pressure (MAP), measured in mmHg, will be used to assess perioperative hemodynamic changes associated with opioid-free versus opioid-based anesthesia. Baseline MAP will be defined as the measurement obtained before study drug infusion. The secondary outcome will be the change from baseline in MAP at each specified time point. MAP will be calculated using the standard formula:
MAP = (Systolic Blood Pressure + 2 × Diastolic Blood Pressure) / 3.
Measured: Baseline, after infusion, after induction, after intubation, 15 minutes, 30 minutes, 1 hour, immediately after extubation, 5 minutes after extubation, and 30 minutes after extubation.
Change From Baseline in Heart Rate
Heart rate (HR), measured in beats per minute (bpm), will be recorded to assess perioperative hemodynamic responses. Baseline HR will be defined as the measurement obtained before study drug infusion. The secondary outcome will be the change from baseline in HR at each specified time point.
Measured: Baseline, after infusion, after induction, after intubation, 15 minutes, 30 minutes, 1 hour, immediately after extubation, 5 minutes after extubation, and 30 minutes after extubation.
Change From Baseline in Quality of Recovery Score (QoR-40)
Quality of recovery will be assessed using the Quality of Recovery-40 questionnaire (QoR-40), a validated patient-reported outcome measure consisting of 40 items across five domains (emotional state, physical comfort, psychological support, physical independence, and pain). The total score ranges from 40 to 200, where higher scores indicate better quality of recovery.
Baseline QoR-40 will be defined as the score obtained preoperatively. The secondary outcome will be the change from baseline in total QoR-40 score comparing opioid-free and opioid-based anesthesia approaches.
Measured: Preoperatively (baseline) and 24 hours postoperatively.
Need for Rescue Analgesia
The need for rescue analgesia will be assessed during the first 24 hours postoperatively. Rescue analgesia will consist of intravenous ketorolac 30 mg, administered according to the study protocol.
The secondary outcome will include:
The proportion of participants requiring rescue analgesia, and
Time to first analgesic request, defined as the time elapsed (in minutes) from the end of surgery to the first request for rescue analgesia (IV ketorolac 30 mg), and
Total rescue analgesic consumption, defined as the total dose of ketorolac (mg) administered within the first 24 hours postoperatively.
A higher proportion of participants requiring rescue analgesia, a shorter time to first analgesic request, and a greater total ketorolac consumption indicate worse postoperative analgesia.
Measured: From the end of surgery up to 24 hours postoperatively.
Postoperative Nausea and Vomiting (PONV)
The incidence and severity of postoperative nausea and vomiting (PONV) will be assessed at 30 minutes, 60 minutes, 90 minutes, and 2 hours postoperatively using a three-point scale:
0 = none
I = mild
II = severe
Both the proportion of participants experiencing PONV and the severity score at each time point will be recorded. Higher scores indicate more severe PONV.
Measured: 30 minutes, 60 minutes, 90 minutes, and 2 hours postoperatively.
Patient and Surgeon Satisfaction
Patient and surgeon satisfaction with the surgical and anesthetic experience will be assessed using a five-point Likert scale, where:
- = Very dissatisfied
- = Dissatisfied
- = Neutral
- = Satisfied
- = Very satisfied
Satisfaction scores will be recorded separately for patients and surgeons at 24 hours postoperatively. Higher scores indicate greater satisfaction.
Measured: 24 hours postoperatively.
Postoperative Sedation Level (Ramsay Sedation Score)
Sedation levels will be assessed using the Ramsay Sedation Score (RSS), a validated scale ranging from 1 to 6, where:
- = Anxious and agitated or restless
- = Cooperative, oriented, and tranquil
- = Responds to commands only
- = Brisk response to light glabellar tap or loud auditory stimulus
- = Sluggish response to light glabellar tap or loud auditory stimulus
- = No response
Higher scores indicate deeper sedation. Sedation will be recorded at 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively.
Measured: 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Group OBA (Opioid-Based Anesthesia): Consisting of 30 participants, this group will receive intravenous fentanyl at a dose of 2 mcg.kg-1 three minutes prior to induction, followed by a fentanyl infusion at 0.5 mcg.kg-¹.h-¹ during the intraoperative period. * Group OFA (Opioid-Free Anesthesia): Comprising 30 participants, this group will receive dexmedetomidine at a dose of 1 mcg.kg-1 via intravenous infusion over 10 minutes prior to induction, followed by a continuous infusion of 0.6 mcg.kg-¹.h-¹ throughout the surgery. Intravenous lignocaine at 1.5 mg.kg-1 will be administered three minutes prior to induction, followed by an intraoperative infusion at 1.5 mg.kg-¹.h-¹.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohsen Zakaria Afia, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350668
- Sponsor's protocol ID
- ms32-12-2024
- Acronym
- Dex/Lido/Fent
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Opioid-Free Anesthesia vs Conventional Opioid-Based Anesthesia for Nasal Surgeries
- ClinicalTrials.gov ID
- NCT07350668
- Acronym / sponsor ID
- Dex/Lido/Fent / ms32-12-2024
- Conditions
- Postoperative Pain
- Keywords
- Opioid-free anesthesia, Opioid-based anesthesia, Opioid Sparing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 20 Jan 2026 (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.
The goal of this clinical trial is to evaluate and compare the efficacy, onset, duration of action, analgesic effect, and side effects of opioid-free anesthesia using dexmedetomidine and lignocaine versus conventional opioid-based anesthesia using fentanyl in patients undergoing nasal surgeries, including functional endoscopic sinus surgery (FESS) and septoplasty. The main questions it aims to answer are:
- What is the effect of opioid-free anesthesia vs opioid-based anesthesia on VAS score ?
- What is the effect of opioid-free anesthesia vs opioid-based anesthesia on postoperative complications including nausea and vomiting , postoperative Ramsay sedation score, amount of rescue analgesia , hemodynamic stability and patient satisfaction ? patients will be divided into two equal groups:
- Group OBA (Opioid-Based Anesthesia): Consisting of 30 participants, this group will receive intravenous fentanyl at a dose of 2 mcg.kg-1 three minutes prior to induction, followed by a fentanyl infusion at 0.5 mcg.kg-¹.h-¹ during the intraoperative period.
- Group OFA (Opioid-Free Anesthesia): Comprising 30 participants, this group will receive dexmedetomidine at a dose of 1 mcg.kg-1 via intravenous infusion over 10 minutes prior to induction, followed by a continuous infusion of 0.6 mcg.kg-¹.h-¹ throughout the surgery. Intravenous lignocaine at 1.5 mg.kg-1 will be administered three minutes prior to induction, followed by an intraoperative infusion at 1.5 mg.kg-¹.h-¹.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- * Group OBA (Opioid-Based Anesthesia): Consisting of 30 participants, this group will receive intravenous fentanyl at a dose of 2 mcg.kg-1 three minutes prior to induction, followed by a fentanyl infusion at 0.5 mcg.kg-¹.h-¹ during the intraoperative period. * Group OFA (Opioid-Free Anesthesia): Comprising 30 participants, this group will receive dexmedetomidine at a dose of 1 mcg.kg-1 via intravenous infusion over 10 minutes prior to induction, followed by a continuous infusion of 0.6 mcg.kg-¹.h-¹ throughout the surgery. Intravenous lignocaine at 1.5 mg.kg-1 will be administered three minutes prior to induction, followed by an intraoperative infusion at 1.5 mg.kg-¹.h-¹.
| Arm | Type | Receives |
|---|---|---|
| dex and lido | Active comparator | Drug: dexmedetomidine and lignocaine infusionthis group will receive dexmedetomidine at a dose of 1 mcg.kg-1 via intravenous infusion over 10 minutes prior to induction, followed by a continuous infusion of 0.6 mcg.kg-¹.h-¹ throughout the surgery. Intravenous lignocaine at 1.5 mg.kg-1 will be administered three minutes prior to induction, followed by an intraoperative infusion at 1.5 mg.kg-¹.h-¹. |
| Fent | Active comparator | Drug: Fentanyl infusionthis group will receive intravenous fentanyl at a dose of 2 mcg.kg-1 three minutes prior to induction, followed by a fentanyl infusion at 0.5 mcg.kg-¹.h-¹ during the intraoperative period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients between the ages of 18 and 60, scheduled to undergo elective nasal surgeries.
- ASA (American Society of Anesthesiologists) physical status I-II.
- Patients who provide written informed consent to participate in the study.
Key exclusion criteria (5 listed)
- ASA III or above.
- Patients with a history of opioid dependence or chronic pain conditions requiring long-term opioid therapy.
- Patients with multiorgan failure, unstable hemodynamics prior to surgery, or scheduled for emergency surgery.
- Pregnant or lactating women.
- Patients with a history of severe asthma or those taking preoperative alpha-blockers.
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 |
|---|---|---|
| dexmedetomidine and lignocaine infusionthis group will receive dexmedetomidine at a dose of 1 mcg.kg-1 via intravenous infusion over 10 minutes prior to induction, followed by a continuous infusion of 0.6 mcg.kg-¹.h-¹ throughout the surgery. Intravenous lignocaine at 1.5 mg.kg-1 will be administered three minutes prior to induction, followed by an intraoperative infusion at 1.5 mg.kg-¹.h-¹. | Drug | dex and lido |
| Fentanyl infusionthis group will receive intravenous fentanyl at a dose of 2 mcg.kg-1 three minutes prior to induction, followed by a fentanyl infusion at 0.5 mcg.kg-¹.h-¹ during the intraoperative period. | Drug | Fent |
Primary outcome
Change From Baseline in Postoperative Pain Intensity
Time frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperatively.
Postoperative pain intensity will be assessed using the Visual Analog Scale for Pain (VAS), which ranges from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. Baseline pain score will be defined as the VAS score measured immediately after arrival to the post-anesthesia care unit (PACU). The primary outcome will be the change from baseline in VAS pain scores at each postoperative assessment time point, comparing opioid-free and opioid-based anesthesia approaches
7 secondary outcomes
Change From Baseline in Mean Arterial Pressure
Time frame: Baseline, after infusion, after induction, after intubation, 15 minutes, 30 minutes, 1 hour, immediately after extubation, 5 minutes after extubation, and 30 minutes after extubation.
Change From Baseline in Heart Rate
Time frame: Baseline, after infusion, after induction, after intubation, 15 minutes, 30 minutes, 1 hour, immediately after extubation, 5 minutes after extubation, and 30 minutes after extubation.
Change From Baseline in Quality of Recovery Score (QoR-40)
Time frame: Preoperatively (baseline) and 24 hours postoperatively.
Need for Rescue Analgesia
Time frame: From the end of surgery up to 24 hours postoperatively.
Postoperative Nausea and Vomiting (PONV)
Time frame: 30 minutes, 60 minutes, 90 minutes, and 2 hours postoperatively.
Patient and Surgeon Satisfaction
Time frame: 24 hours postoperatively.
Postoperative Sedation Level (Ramsay Sedation Score)
Time frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively.
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 23 Jan 2026.
- Individual participant dataSharing planned: No
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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 3 study testing dexmedetomidine and lignocaine infusion and Fentanyl infusion in people with Postoperative Pain, run by Benha University at 1 site in Egypt.
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 5 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 23 Jan 2026. 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 Egypt. 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 phase mean?
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?
Change From Baseline in Postoperative Pain Intensity (time frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperatively.). 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 23 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.