Effect of Opioid-Free Versus Opioid-Based Anesthesia in Discectomy Surgery

NCT07787858 | Completed

• 1 other identifier: Zagazig-OFA-Discectomy
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized double-blind clinical trial compares opioid-free anesthesia (OFA) versus opioid-based anesthesia (OBA) on postoperative analgesia in patients undergoing elective lumbar discectomy surgeries at Zagazig University Hospitals. Forty-six adult patients (ASA I-II, aged 21-64) will be randomly allocated to two groups. Group F (OFA) receives dexmedetomidine (loading 1 µg/kg, infusion 0.2-0.7 µg/kg/hr) and ketamine (0.25-0.5 mg/kg, infusion 0.1-0.3 mg/kg/hr). Group B (OBA) receives fentanyl (2 µg/kg bolus, 1 µg/kg/hr infusion). Both groups receive propofol maintenance. Primary outcome is postoperative pain intensity measured by Visual Analog Scale (0-10) at baseline, 2, 6, 12, and 24 hours. Secondary outcomes include total analgesic consumption in 24 hours, time to first rescue analgesia, intraoperative hemodynamic stability (BP, MAP, HR, RR), recovery time (to responsiveness), sedation depth (Modified Ramsay Score), PACU discharge time, patient satisfaction, and incidence of opioid-related adverse effects (nausea, vomiting, respiratory depression). The study hypothesizes that OFA provides comparable analgesia with fewer opioid-related complications. As the first such study at Zagazig University, it addresses the critical need for effective non-opioid pain management in spine surgery, contributing to safer practices amid global opioid concerns.

Conditions

Postoperative Pain Intensity

Keywords

Opioid-free; Opioid-based; dexmedetomidine; Ketamine; fentanyl

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  Pain assessed using the Visual Analog Scale (VAS, 0-10)

  24 hours postoperatively (at baseline, 2, 6, 24 hours)

Secondary Outcomes (7)

• Intraoperative Mean arterial pressure (MAP)

  Intraoperative period

• Intraoperative Heart Rate (HR)

  Intraoperative period

• Total postoperative analgesic consumption

  First 24 hours postoperatively

• Recovery time

  Perioperative period

• Modified Ramsay Sedation Score

  From immediately postoperatively through 24 hours postoperatively

Study Arms (2)

Opioid-free Anesthesia

EXPERIMENTAL

Opioid-free anesthesia protocol using dexmedetomidine (loading 1 µg/kg, then 0.2-0.7 µg/kg/hr) and ketamine (0.25-0.5 mg/kg, then 0.1-0.3 mg/kg/hr) infusions alongside propofol for maintenance.

Combination Product: Dexmedetomidine and Ketamine-based Opioid-free Anesthesia

Opioid-based Anesthesia

ACTIVE COMPARATOR

Standard opioid-based anesthesia using fentanyl (2 µg/kg bolus then 1 µg/kg/hr infusion) with propofol maintenance (4-12 mg/kg/hr). This is the traditional anesthetic technique against which the opioid-free approach is compared.

Drug: Fentanyl-based Opioid Anesthesia

Interventions

Dexmedetomidine and Ketamine-based Opioid-free Anesthesia COMBINATION_PRODUCT

Patients will receive: 1) Dexmedetomidine loading dose 1 µg/kg over 10 min, then infusion 0.2-0.7 µg/kg/hr; 2) Ketamine 0.25-0.5 mg/kg IV at induction, then infusion 0.1-0.3 mg/kg/hr; 3) Propofol infusion (4-12 mg/kg/hr) for anesthesia maintenance.

Also known as: OFA

Opioid-free Anesthesia

Fentanyl-based Opioid Anesthesia DRUG

Patients will receive: 1) Fentanyl 2 µg/kg IV at induction, followed by continuous infusion of 1 µg/kg/hr; 2) Propofol infusion (4-12 mg/kg/hr) for anesthesia maintenance.

Also known as: OBA

Opioid-based Anesthesia

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients' acceptance.
• Age : adult patients aged 21-64 years.
• Sex : both male and female.
• Physical state : Patients classified as American Society of Anesthesiologists (ASA) physical status I-II
• BMI : \< 35 kg/ m2
• Patients scheduled for elective destectomy surgery under general anesthesia with an Expected duration of ≥ 3 hours.

You may not qualify if:

• Known allergy or contraindication to any study medications (e.g., dexmedetomidine, ketamine, lidocaine, opioids).
• History of chronic opioid use or opioid dependence.
• Psychiatric or neurological disorders interfering with pain assessment (e.g., cognitive impairment).
• Pregnancy or breastfeeding.
• Patients on medications that interact significantly with OBA agents (e.g., MAO inhibitors).

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Egypt

Location

Related Publications (9)

• Swamy AHM, Sneka G, Kumararadhya GB, Chennabasappa A, Shivakumar KG, Umesh S. Effects of Opioid-based and Opioid-free Anesthesia in Patients Undergoing Elective Laparoscopic Surgeries. Ann Afr Med. 2025 Apr 1;24(2):317-323. doi: 10.4103/aam.aam_137_24. Epub 2025 Feb 27.

  PMID: 40019119 BACKGROUND

• Segebarth PB, Schallmo M, Odum S, Hietpas K, Michalek C, Chapman TM Jr, Leas D, Milam RA, Hamid N; CORE Research Group. Opioid-Free Analgesia is Safe and Effective in Anterior Cervical Spine Surgery: A Randomized Controlled Trial. Clin Spine Surg. 2024 May 1;37(4):138-148. doi: 10.1097/BSD.0000000000001608. Epub 2024 Mar 28.

  PMID: 38553433 BACKGROUND

• Rani US, Panda NB, Chauhan R, Mahajan S, Kaloria N, Tripathi M. Comparison of the effects of opioid-free anesthesia (OFA) and opioid-based anesthesia (OBA) on postoperative analgesia and intraoperative hemodynamics in patients undergoing spine surgery: A prospective randomized double-blind controlled trial. Saudi J Anaesth. 2024 Apr-Jun;18(2):173-180. doi: 10.4103/sja.sja_341_23. Epub 2024 Mar 14.

  PMID: 38654849 BACKGROUND

• Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.

  PMID: 4835444 BACKGROUND

• Mathew DM, Fusco PJ, Varghese KS, Awad AK, Vega E, Mathew SM, Polizzi M, George J, Mathew CS, Thomas JJ, Calixte R, Ahmed A. Opioid-free anesthesia versus opioid-based anesthesia in patients undergoing cardiovascular and thoracic surgery: a meta-analysis and systematic review. Semin Cardiothorac Vasc Anesth. 2023 Sep;27(3):162-170. doi: 10.1177/10892532231180227. Epub 2023 Jun 10.

  PMID: 37300532 BACKGROUND

• Mahdy, E. W., Mohammed, E. A., & Abdelwahab, Z. M. (2024). Comparative Study between Opioid-Free Anesthesia and Opioid-Based Anesthesia in Obese Patients Undergoing Abdominal Laparoscopic Surgery? Effective and Safe Analgesia Challenge: A Randomized Double Blinded Study. Egyptian Journal of Hospital Medicine, 97(1): 4261-7.

  BACKGROUND

• Kalagara R, Bhoi D, Subramaniam R, Baidya DK, Maitra S, Talawar P. Comparison between opioid-based anaesthesia technique and opioid-free anaesthesia technique in patients undergoing laparotomy for gynaecological malignancy: A randomised controlled trial. Indian J Anaesth. 2025 Mar;69(3):261-267. doi: 10.4103/ija.ija_151_24. Epub 2025 Feb 17.

  PMID: 40161920 BACKGROUND

• Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.

  PMID: 3785962 BACKGROUND

• Elahwal, L., Elmazny, M., & Elrahwan, S. M. (2023). The perioperative analgesic effect of opioid free anesthesia using combination of dexmedetomidine, ketamine and lidocaine in adolescent patients undergoing Scoliosis Surgery; A randomized Controlled Trial. Egyptian Journal of Anaesthesia, 39(1): 650-6.

  BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dr Asmaa Mohamed Galal Eldin, Assist Prof

  faculty of medicine zagazig university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of anesthesia and Intensive Care

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 26, 2026
• Study Start: January 15, 2026
• Primary Completion: July 16, 2026
• Study Completion: July 16, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: planned after the completion of the study and publication
• Access Criteria: principal investigator

Locations

EG (1)