Effect of Nalbuphine on Hemodynamic Response During Laryngoscopy and Intubation

NCT ID: NCT07348159

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-12-15

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.

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.

Conditions

Hemodynamic Response to Laryngoscopy and Orotracheal Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Normal saline IV

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Nalbuphine 0.2 mg/kg

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hayatabad Medical Complex

OTHER_GOV

Sponsor Role: collaborator

Dr. Waseem Ullah

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Waseem Ullah

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hayatabad Medical Complex

Peshawar, Khyber Pakhtunkhwa, Pakistan

Countries

Pakistan

Other Identifiers

HMC-GAD-F 2231

Identifier Type: -

Identifier Source: org_study_id