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Evaluation of pain control, rate of awakening, and airway quality after simultaneous intravenous administration of fentanyl (5 micrograms per kilogram of body weight) and morphine (5 mg) in posterior spinal fusion surgery patients at Akhtar hospital: A case series study

Protocol summary

Study aim
To evaluate pain control, awakening time, and airway safety after simultaneous intravenous administration of fentanyl and morphine in patients undergoing elective posterior lumbar spinal fusion surgery under general anesthesia.
Design
Prospective, single arm, observational case series conducted at a single center. Sixty participants will be enrolled consecutively. No randomization or blinding will be performed.
Settings and conduct
The study will be conducted in the operating rooms and post anesthesia care unit of the study hospital. Participants will be followed from induction of anesthesia until 24 hours after surgery using a standardized perioperative care protocol.
Participants/Inclusion and exclusion criteria
Adults aged 18 to 65 years with American Society of Anesthesiologists physical status I to III undergoing elective posterior lumbar spinal fusion are eligible. Patients with opioid allergy, severe hepatic or renal impairment, chronic opioid use, substance abuse, severe chronic respiratory disease, pregnancy, breastfeeding, or inability to provide informed consent are excluded.
Intervention groups
All participants receive intravenous fentanyl at 5 micrograms per kilogram and intravenous morphine at 5 milligrams during induction of general anesthesia according to a standardized anesthetic protocol.
Main outcome variables
Pain intensity measured by the Visual Analogue Scale; awakening time from discontinuation of anesthesia to appropriate verbal response; airway safety including oxygen desaturation, hypoventilation, apnea, and need for airway intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260203068755N2
Registration date: 2026-08-03, 1405/05/12
Registration timing: prospective

Last update: 2026-08-03, 1405/05/12
Update count: 0
Registration date
2026-08-03, 1405/05/12
Registrant information
Name
Shayan Kamalfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2615 7609
Email address
shayankalamfar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-09-06, 1405/06/15
Expected recruitment end date
2026-11-06, 1405/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of pain control, rate of awakening, and airway quality after simultaneous intravenous administration of fentanyl (5 micrograms per kilogram of body weight) and morphine (5 mg) in posterior spinal fusion surgery patients at Akhtar hospital: A case series study
Public title
Effect of Simultaneous Intravenous Fentanyl and Morphine on Pain Relief and Recovery After Lumbar Spine Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults aged 18 to 65 years American Society of Anesthesiologists (ASA) physical status I–III. Scheduled for elective posterior lumbar spinal fusion under general anesthesia. Body weight between 60 and 100 kg. Able to provide written informed consent.
Exclusion criteria:
Known allergy or hypersensitivity to fentanyl, morphine, or other opioids. Severe hepatic impairment (Child–Pugh class C). Severe renal impairment (eGFR <30 mL/min/1.73 m²). Chronic opioid use or opioid dependence. History of substance abuse. Severe chronic respiratory disease (such as chronic obstructive pulmonary disease). Pregnancy or breastfeeding. Inability to provide informed consent.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
School of Medicine - Shahid Beheshti University of Medical Sciences (Research Ethics Committee)
Street address
Shahid Chamran Highway- Evin- next to Taleghani Hospital- Medical School- third floor
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2026-06-22, 1405/04/01
Ethics committee reference number
IR.SBMU.MSP.REC.1405.219

Health conditions studied

1

Description of health condition studied
Lumbar degenerative spine disorders requiring elective posterior lumbar spinal fusion surgery
ICD-10 code
M00-M99
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
Postoperative pain intensity measured using the Visual Analogue Scale.
Timepoint
At admission to the post anesthesia care unit, and at 2, 4, 6, 12, and 24 hours after surgery.
Method of measurement
Pain intensity will be assessed using the ten centimeter Visual Analogue Scale, with scores ranging from zero, indicating no pain, to ten, indicating the worst imaginable pain.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants will receive intravenous fentanyl at a dose of 5 micrograms per kilogram of body weight and intravenous morphine at a fixed dose of 5 milligrams simultaneously during induction of general anesthesia. General anesthesia will be induced with propofol and maintained with sevoflurane according to the hospital's standard anesthetic protocol. Standard postoperative analgesia and prophylaxis for postoperative nausea and vomiting will be provided according to institutional practice.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhtar hospital
Full name of responsible person
Shayan Kamalfar
Street address
Akhtar Hospital - Azar Dead End - Sharifi Manesh Street - In front of Qaitariya metro - Shariati Avenue - Tehran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 912 524 4590
Email
shayankamalfar@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziayi
Street address
Shahid Chamran Highway- Evin- next to Taleghani Hospital- Medical School- third floor
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2254 9951
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shayan Kamalfar
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Highway- Evin- next to Taleghani Hospital- Medical School- third floor
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 922 769 5794
Email
shayankamalfar@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
ُShayan Kamalfar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Highway- Evin- next to Taleghani Hospital- Medical School- third floor
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2303 1290
Email
shayankamalfar@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shayan Kmalfar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Highway- Evin- next to Taleghani Hospital- Medical School- third floor
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2303 1290
Fax
Email
shayankamalfar@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data regarding anesthesia and outcomes measurements will be available.
When the data will become available and for how long
After data collection completion
To whom data/document is available
Other researchers
Under which criteria data/document could be used
belonging to academic institution
From where data/document is obtainable
researcher's personal email shayankamalfar@sbmu.ac.ir
What processes are involved for a request to access data/document
requesting by email
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