Effect of Nalbuphine on Hemodynamic Response During Laryngoscopy and Intubation (NAL-HRI)

Efficacy of Nalbuphine in Attenuation of Hemodynamic Response to Laryngoscopy and Orotracheal Intubation: A Randomized Controlled Trial

Laryngoscopy and placement of a breathing tube during general anesthesia can cause temporary increases in blood pressure and heart rate. These changes may be harmful in some patients. Nalbuphine is an opioid pain medicine that may reduce these cardiovascular responses.

This study evaluated whether intravenous nalbuphine, given before anesthesia induction, reduces changes in mean arterial blood pressure during laryngoscopy and orotracheal intubation compared with placebo (normal saline).

Adult patients undergoing elective surgery under general anesthesia were randomly assigned to receive either nalbuphine or placebo before anesthesia. Blood pressure was measured before drug administration, during intubation, and for several minutes afterward. The results of this study may help guide safe medication use to maintain blood pressure stability during airway management.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Response to Laryngoscopy and Orotracheal Intubation
• Intervention / Treatment: Drug: Normal saline IV; Drug: Nalbuphine 0.2 mg/kg

Detailed Description

Laryngoscopy and orotracheal intubation are essential components of general anesthesia but are associated with a sympathoadrenal stress response caused by stimulation of the laryngeal and pharyngeal structures. This response may result in transient hypertension and tachycardia due to catecholamine release. Although often well tolerated in healthy individuals, these hemodynamic changes can be undesirable and potentially harmful, particularly in patients with limited cardiovascular reserve.

Opioids have been widely used to attenuate the hemodynamic response to airway manipulation. Nalbuphine is a synthetic opioid with kappa receptor agonist and mu receptor antagonist properties. It provides analgesia with a ceiling effect on respiratory depression and has a lower risk of certain opioid-related adverse effects compared with pure mu agonists. Despite these potential advantages, data regarding the effectiveness of nalbuphine in attenuating intubation-related hemodynamic responses remain limited.

This prospective, randomized, controlled trial was conducted at Hayatabad Medical Complex, Peshawar, Pakistan, between March 2024 and December 2024. Adult patients aged 18 to 60 years with American Society of Anesthesiologists (ASA) physical status I, scheduled for elective surgery under general anesthesia requiring orotracheal intubation, were enrolled. Patients with anticipated difficult airways, cardiovascular disease, hypertension, hepatic or renal disease, pregnancy, opioid allergy, or use of interacting medications were excluded.

Eligible participants were randomly allocated into two groups. The intervention group received intravenous nalbuphine at a dose of 0.2 mg/kg, while the control group received an equivalent volume of normal saline. The study drug was administered five minutes before induction of anesthesia. Anesthesia induction was standardized using propofol and atracurium, followed by Macintosh laryngoscopy and orotracheal intubation performed by experienced anesthetists.

Hemodynamic parameters were recorded at baseline, three minutes after administration of the study drug, immediately after intubation, and at one-minute intervals for five minutes following intubation. The primary outcome measure was mean arterial pressure after laryngoscopy and intubation. Adverse events, including bradycardia, hypotension, nausea, respiratory depression, and other complications, were monitored intraoperatively.

The purpose of this study was to determine whether nalbuphine premedication provides better attenuation of the hemodynamic response to laryngoscopy and intubation compared with placebo in healthy adult patients undergoing elective surgery.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
      • Hayatabad Medical Complex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Patients scheduled for elective surgery under general anesthesia requiring laryngoscopy and orotracheal intubation.

American Society of Anesthesiologists (ASA) physical status I or II. Age between 18 and 60 years. Both male and female patients. Patients who provide written informed consent.

Exclusion Criteria:

Known hypersensitivity to nalbuphine or any opioids. History of cardiovascular disease, including uncontrolled hypertension, arrhythmias, or ischemic heart disease.

Patients with respiratory disorders such as asthma, chronic obstructive pulmonary disease, or significant respiratory compromise.

Patients with renal or hepatic impairment. Pregnant or lactating women. Patients on medications affecting hemodynamic response (e.g., beta-blockers, calcium channel blockers).

Emergency surgeries. Patients with anticipated difficult airway (Mallampati class III or IV).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (Normal Saline); Participants in this arm received intravenous normal saline in a volume equivalent to the intervention drug. The placebo was administered five minutes before induction of general anesthesia, followed by standardized induction with propofol and atracurium, laryngoscopy, and orotracheal intubation.	Drug: Normal saline IV; Intravenous administration of normal saline in a volume equivalent to the nalbuphine dose, 5 minutes prior to induction of general anesthesia for elective surgery. This serves as a placebo control to compare the effect of nalbuphine on attenuation of the hemodynamic response (mean arterial pressure and heart rate) during laryngoscopy and orotracheal intubation. Standard monitoring is applied during the procedure. Any adverse events are recorded similarly to the experimental group.
Experimental: Nalbuphine 0.2 mg/kg; Participants in this arm received intravenous nalbuphine at a dose of 0.2 mg/kg administered five minutes before induction of general anesthesia. Induction was standardized using propofol and atracurium, followed by laryngoscopy and orotracheal intubation.	Drug: Nalbuphine 0.2 mg/kg; Intravenous nalbuphine at a dose of 0.2 mg/kg administered 5 minutes prior to induction of general anesthesia for elective surgery. The purpose of administration is to attenuate the hemodynamic response, specifically mean arterial pressure and heart rate changes, associated with laryngoscopy and orotracheal intubation. Standard monitoring is applied during the procedure, including continuous ECG, non-invasive blood pressure, pulse oximetry, and capnography. Any adverse events such as mild bradycardia or nausea are recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Arterial Pressure (MAP) change following laryngoscopy and orotracheal intubation	MAP will be measured at baseline (before drug administration), 3 minutes after administration of nalbuphine or placebo, immediately after intubation, and at 1-minute intervals for the subsequent 5 minutes. The primary outcome is the difference in MAP between the nalbuphine group and the saline control group, reflecting the efficacy of nalbuphine in attenuating the hemodynamic response to laryngoscopy and intubation.	Immediately after intubation and at 1-minute intervals for 5 minutes post-intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate (HR) change	HR will be recorded alongside MAP at the same time points. The difference between groups will indicate the effect of nalbuphine on tachycardia associated with airway manipulation.	Immediately after intubation and at 1-minute intervals for 5 minutes post-intubation
Incidence of adverse events	Adverse events such as mild bradycardia (HR 50-55 bpm), hypotension (MAP <60 mmHg), transient hypertension (MAP >110 mmHg), nausea, respiratory depression, and allergic reactions will be recorded. The frequency and severity of these events will be compared between nalbuphine and control groups.	Intraoperative and immediate postoperative period

Collaborators and Investigators

• Sponsor: Dr. Waseem Ullah
• Collaborators: Hayatabad Medical Complex

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): December 15, 2024

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Laryngoscopy; General Anesthesia; Nalbuphine; Orotracheal Intubation; Hemodynamic Response; Mean Arterial Pressure; Opioid Premedication
• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Nalbuphine
• Other Study ID Numbers: HMC-GAD-F 2231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data, study protocol, and statistical analysis plan will be made available upon reasonable request to researchers after publication of the study results, for a period of 5 years.
• IPD Sharing Time Frame: IPD and supporting documents will be available starting 6 months after publication of the primary results and will remain available for 5 years thereafter.
• IPD Sharing Access Criteria: Access will be granted to researchers with a scientifically sound proposal. Data will be provided after approval of the request and signing of a data use agreement. Researchers will have access to de-identified participant data, study protocol, SAP, and ICF.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No