Opioid-Free vs Opioid-Based Anesthesia for Nasal Surgeries

NCT07350668 | Completed Phase 3

• 1 other identifier: ms32-12-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Opioid-free anesthesia; Opioid-based anesthesia; Opioid Sparing

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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)

  Preoperatively (baseline) and 24 hours postoperatively.

• Need for Rescue Analgesia

  From the end of surgery up to 24 hours postoperatively.

• Postoperative Nausea and Vomiting (PONV)

  30 minutes, 60 minutes, 90 minutes, and 2 hours postoperatively.

Study Arms (2)

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.

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.

Drug: Fentanyl infusion

Interventions

Fentanyl infusion DRUG

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.

Fent

dexmedetomidine and lignocaine infusion DRUG

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.

dex and lido

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: the study is double-blinded (patient and outcome assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: * 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 Record Dates

• First Submitted: December 31, 2025
• First Posted: January 20, 2026
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)