Postoperative Pain
Conditions
Keywords
Opioid-free anesthesia, Opioid-based anesthesia, Opioid Sparing
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.
Interventions
DRUGdexmedetomidine and lignocaine infusion
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.
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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
the study is double-blinded (patient and outcome assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Postoperative Pain Intensity | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| Change From Baseline in Quality of Recovery Score (QoR-40) | Preoperatively (baseline) and 24 hours postoperatively. | 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. |
| Need for Rescue Analgesia | From the end of surgery up to 24 hours postoperatively. | 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. |
| Postoperative Nausea and Vomiting (PONV) | 30 minutes, 60 minutes, 90 minutes, and 2 hours postoperatively. | 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. |
| Patient and Surgeon Satisfaction | 24 hours postoperatively. | Patient and surgeon satisfaction with the surgical and anesthetic experience will be assessed using a five-point Likert scale, where: 1. = Very dissatisfied 2. = Dissatisfied 3. = Neutral 4. = Satisfied 5. = Very satisfied Satisfaction scores will be recorded separately for patients and surgeons at 24 hours postoperatively. Higher scores indicate greater satisfaction. |
| Postoperative Sedation Level (Ramsay Sedation Score) | 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively. | Sedation levels will be assessed using the Ramsay Sedation Score (RSS), a validated scale ranging from 1 to 6, where: 1. = Anxious and agitated or restless 2. = Cooperative, oriented, and tranquil 3. = Responds to commands only 4. = Brisk response to light glabellar tap or loud auditory stimulus 5. = Sluggish response to light glabellar tap or loud auditory stimulus 6. = 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. |
Countries
Egypt
Outcome results
None listed