LaryngoscopyPhase 4NCT07435337
Effect of Nalbuphine Versus Fentanyl on Hemdoynamic Effects of Laryngoscopy
A Phase 4 study testing Nalbuphine and Fentanyl in people with Laryngoscopy and Hemodynamic Changes, run by Rawalpindi Institute of Cardiology at 1 site in Pakistan.
Trial summary
Participants will undergo routine pre-operative evaluation. An intravenous line will be placed in the recovery area. On arrival in the operating room, standard monitoring (blood pressure, heart rate, oxygen saturation, ECG, breathing monitor, and temperature) will be applied. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngoscopy, Hemodynamic Changes
- What is being tested?
- Nalbuphine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Feb 2026to 21 May 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weighing 40-70kg
- ASA III of either sex
- Undergoing cardiac surgery with CPB
Who cannot join
- History of Drug Allergy • Pre-existing Asthma • Renal or Hepatic dysfunction • Extreme obesity • Pregnant / lactating patients • Difficult intubation/prolonged intubation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Deparment of Anesthesia, Rawalpindi Institute of Cardiology, Rawalpindi
Rawalpindi, Punjab Province, 46000
Ayemon Fatima Principal Investigator, MBBS, +92 321 1579066, ayemonfatima@gmail.com
About this study
Official title: COMPARISON OF HEMODYNAMIC EFFECTS OF NALBUPHINE VERSUS FENTANYL: A RANDOMIZED, DOUBLE-BLINDED INTERVENTIONAL STUDY IN PATIENTS ON CARDIOPULMONARY BYPASS AT RAWALPINDI INSTITUTE OF CARDIOLOGY, RAWALPINDI
Participants will undergo routine pre-operative evaluation. An intravenous line will be placed in the recovery area. On arrival in the operating room, standard monitoring (blood pressure, heart rate, oxygen saturation, ECG, breathing monitor, and temperature) will be applied. A central venous catheter and an arterial line will be inserted under local anesthesia using sterile technique.
Before anesthesia induction, patients will receive premedication including midazolam and an opioid pain-relief injection given slowly through the vein. General anesthesia will then be induced with etomidate. After adequate sedation, a muscle relaxant (atracurium) will be administered, and the patient will be ventilated with 100% oxygen using a face mask. The breathing tube will then be inserted and correct placement confirmed.
During surgery, anesthesia will be maintained with oxygen, sevoflurane gas, and a continuous atracurium infusion. Hemodynamic parameters such as heart rate and blood pressure will be monitored throughout the peri-intubation and intraoperative period.
Read the detailed description
Participants will undergo standard preoperative assessment and will receive oral alprazolam 0.5 mg the night before surgery. Intravenous access will be established in the recovery area. Upon arrival in the operating room, standard monitoring will be applied, including non-invasive blood pressure, pulse oximetry, electrocardiography, capnography, and temperature monitoring. Under aseptic conditions and local anesthesia, a central venous catheter will be inserted into the internal jugular vein and an arterial line into the radial artery.
Premedication with intravenous midazolam 0.01 mg/kg will be administered and baseline parameters recorded. An opioid analgesic (nalbuphine 0.2 mg/kg or fentanyl 3 µg/kg) will be given intravenously over 5 minutes prior to induction of anesthesia. General anesthesia will be induced with intravenous etomidate 0.3 mg/kg. After adequate sedation, atracurium 0.5 mg/kg will be administered to facilitate neuromuscular blockade, followed by bag-mask ventilation with 100% oxygen. Endotracheal intubation will then be performed under direct laryngoscopy, with confirmation of bilateral air entry and secure fixation of the tube.
Anesthesia will be maintained with 60% oxygen in air, sevoflurane (approximately 2 MAC), and a continuous atracurium infusion (5-12 µg/kg/min). Hemodynamic parameters including heart rate and arterial blood pressure will be continuously monitored during the peri-intubation and intraoperative period.
- Conditions
- Laryngoscopy, Hemodynamic Changes
- Being tested
- Nalbuphine, Fentanyl
- Keywords
- Laryngoscopic stress response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
IV Nalbuphine at dose of 0.2 mg/kg will be given 5 minutes before induction of anesthesia
FentanylDrug
3 Microgram per kilogram body weight IV Fentanyl will be given 5 minutes before induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group Nalbuphine | Active comparator | Participants will receive an injection of nalbuphine 0.2 mg/kg intravenous slowly over 5 minutes before induction. Receives: Drug: Nalbuphine |
| Group Fentanyl | Active comparator | Participants will receive an injection of fentanyl 3 µg/kg intravenous slowly over 5 min before induction. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Measured: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation
Systolic Blood Pressure
Measured: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation
Diastolic Blood Pressure
Measured: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation
Mean Blood Pressure
Measured: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start21 Feb 2026
- Primary completion21 May 2026 (estimated)
- Study completion21 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LaryngoscopyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Institute of Cardiology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ayemon Fatima, Rawalpindi Institute of Cardiology
- Investigators
- Qudsia Qureshi, MBBS, Study chair, Head of Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435337
- Sponsor's protocol ID
- RIC/RERC/29/26
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Hospital ethical committe doesnt allow data sharing
Publications
Saiyed A, Sharma S, Hussain A. Comparison of analgesic and hemodynamic effects of nalbuphine versus fentanyl: a randomized, double-blinded interventional study in patients on cardiopulmonary bypass. Egypt J Cardiothorac Anesth. 2020;14(2):44.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF HEMODYNAMIC EFFECTS OF NALBUPHINE VERSUS FENTANYL: A RANDOMIZED, DOUBLE-BLINDED INTERVENTIONAL STUDY IN PATIENTS ON CARDIOPULMONARY BYPASS AT RAWALPINDI INSTITUTE OF CARDIOLOGY, RAWALPINDI
- ClinicalTrials.gov ID
- NCT07435337
- Acronym / sponsor ID
- RIC/RERC/29/26
- Conditions
- Laryngoscopy, Hemodynamic Changes
- Keywords
- Laryngoscopic stress response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Rawalpindi Institute of CardiologyUniversity, hospital or other
- Study start
- 21 Feb 2026 (actual)
- Primary completion
- 21 May 2026 (estimated)
- Study completion
- 21 May 2026 (estimated)
- First posted
- 27 Feb 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.
Participants will undergo routine pre-operative evaluation. An intravenous line will be placed in the recovery area. On arrival in the operating room, standard monitoring (blood pressure, heart rate, oxygen saturation, ECG, breathing monitor, and temperature) will be applied. A central venous catheter and an arterial line will be inserted under local anesthesia using sterile technique.
Before anesthesia induction, patients will receive premedication including midazolam and an opioid pain-relief injection given slowly through the vein. General anesthesia will then be induced with etomidate. After adequate sedation, a muscle relaxant (atracurium) will be administered, and the patient will be ventilated with 100% oxygen using a face mask. The breathing tube will then be inserted and correct placement confirmed.
During surgery, anesthesia will be maintained with oxygen, sevoflurane gas, and a continuous atracurium infusion. Hemodynamic parameters such as heart rate and blood pressure will be monitored throughout the peri-intubation and intraoperative period.
Detailed description
Participants will undergo standard preoperative assessment and will receive oral alprazolam 0.5 mg the night before surgery. Intravenous access will be established in the recovery area. Upon arrival in the operating room, standard monitoring will be applied, including non-invasive blood pressure, pulse oximetry, electrocardiography, capnography, and temperature monitoring. Under aseptic conditions and local anesthesia, a central venous catheter will be inserted into the internal jugular vein and an arterial line into the radial artery.
Premedication with intravenous midazolam 0.01 mg/kg will be administered and baseline parameters recorded. An opioid analgesic (nalbuphine 0.2 mg/kg or fentanyl 3 µg/kg) will be given intravenously over 5 minutes prior to induction of anesthesia. General anesthesia will be induced with intravenous etomidate 0.3 mg/kg. After adequate sedation, atracurium 0.5 mg/kg will be administered to facilitate neuromuscular blockade, followed by bag-mask ventilation with 100% oxygen. Endotracheal intubation will then be performed under direct laryngoscopy, with confirmation of bilateral air entry and secure fixation of the tube.
Anesthesia will be maintained with 60% oxygen in air, sevoflurane (approximately 2 MAC), and a continuous atracurium infusion (5-12 µg/kg/min). Hemodynamic parameters including heart rate and arterial blood pressure will be continuously monitored during the peri-intubation and intraoperative period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Nalbuphine | Active comparator | Drug: NalbuphineParticipants will receive an injection of nalbuphine 0.2 mg/kg intravenous slowly over 5 minutes before induction. |
| Group Fentanyl | Active comparator | Drug: FentanylParticipants will receive an injection of fentanyl 3 µg/kg intravenous slowly over 5 min before induction. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Weighing 40-70kg
Key exclusion criteria (1 listed)
- History of Drug Allergy • Pre-existing Asthma • Renal or Hepatic dysfunction • Extreme obesity • Pregnant / lactating patients • Difficult intubation/prolonged intubation
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 |
|---|---|---|
| NalbuphineIV Nalbuphine at dose of 0.2 mg/kg will be given 5 minutes before induction of anesthesia | Drug | Group Nalbuphine |
| Fentanyl3 Microgram per kilogram body weight IV Fentanyl will be given 5 minutes before induction of anesthesia | Drug | Group Fentanyl |
Primary outcome
Heart Rate
Time frame: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation
Systolic Blood Pressure
Time frame: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation
Diastolic Blood Pressure
Time frame: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation
Mean Blood Pressure
Time frame: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- BackgroundSaiyed A, Sharma S, Hussain A. Comparison of analgesic and hemodynamic effects of nalbuphine versus fentanyl: a randomized, double-blinded interventional study in patients on cardiopulmonary bypass. Egypt J Cardiothorac Anesth. 2020;14(2):44.
- Individual participant dataSharing planned: No. Hospital ethical committe doesnt allow data sharing
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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.
Qudsia Qureshi, MBBS study chair
Head of Department of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nalbuphine and Fentanyl in people with Laryngoscopy and Hemodynamic Changes, run by Rawalpindi Institute of Cardiology at 1 site in Pakistan.
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 1 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: looking for participants now, as of the sponsor's last update on 27 Feb 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 Pakistan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayemon Principal Investigator, MBBS (+923211579066, ayemonfatima@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: Before administration of IV Nalbuphine or Opioid, Immediately before intubation, 1,3,5 and 15 minutes following intubation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07435337, which also lists 1 linked publication.
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 27 Feb 2026.