Effect of Nalbuphine on Hemodynamic Response During Laryngoscopy and Intubation

NCT07348159 | Completed

• 1 other identifier: HMC-GAD-F 2231
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodynamic Response to Laryngoscopy and Orotracheal Intubation

Keywords

Nalbuphine; Laryngoscopy; Orotracheal Intubation; Mean Arterial Pressure; Hemodynamic Response; General Anesthesia; Opioid Premedication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Heart Rate (HR) change

  Immediately after intubation and at 1-minute intervals for 5 minutes post-intubation

• Incidence of adverse events

  Intraoperative and immediate postoperative period

Study Arms (2)

Placebo (Normal Saline)

PLACEBO COMPARATOR

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

Nalbuphine 0.2 mg/kg

EXPERIMENTAL

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

Interventions

Normal saline IV DRUG

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.

Placebo (Normal Saline)

Nalbuphine 0.2 mg/kg DRUG

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.

Nalbuphine 0.2 mg/kg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dr. Waseem Ullah: lead
• Hayatabad Medical Complex: collaborator

Study Sites (1)

Hayatabad Medical Complex

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Interventions

Nalbuphine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to group allocation. Study drugs were prepared by personnel not involved in data collection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomly assigned to one of two parallel groups to receive either intravenous nalbuphine or placebo prior to induction of general anesthesia.

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: March 1, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

PA (1)