NCT06637956

Brief Summary

Numerous preventive medications have been used to lessen the cardiovascular response to laryngoscopy and intubation. Though some advantages have been noted, most of these treatments have not been found to be completely satisfying. However, nitroglycerin is the most widely utilized medicine due to its fast effect, short half-life, and absence of sedative qualities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

October 7, 2024

Last Update Submit

October 9, 2024

Conditions

Keywords

Intranasalnitroglycerinhemodynamic responselarayngoscopyintubationcoronary artery bypass grafting

Outcome Measures

Primary Outcomes (4)

  • Mean aterial pressure

    Mean arterial pressure was measured prior to and after intubation

    5 minutes post intubation

  • Heart rate

    Heart rate was measure prior to and after intubation

    5 minutes post intubation

  • Systolic blood pressure

    Systolic blood pressure was measure prior to and after itubation

    5 minutes post intubation

  • Diastolic blood pressure

    Diastolic blood pressure was measure prior to and after intubation

    5 minutes post intubation

Study Arms (2)

NTG

EXPERIMENTAL

Received a mg nitroglycerin intranasally two minutes prior to laryngoscopy and intubation

Drug: Nitroglycerin (NTG)

Control

NO INTERVENTION

Control group did not receive nitroglycerine prior to laryngoscopy and intubation

Interventions

Received 1 mg of nitroglycerin intranasally two minutes prior to laryngoscopy and intubation

NTG

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders
  • Patients undergoing coronary artery bypass grafting surgery.
  • Patients aged 35-60 years.
  • Ejection Fraction between 50-60%.
  • American Society of Anesthesiologists Classification 3-4.

You may not qualify if:

  • Known hypersensitivity to nitroglycerin.
  • Anticipated difficult airway.
  • Emergency surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, Rashid Latif Medical College

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Interventions

Nitroglycerin

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

Study Officials

  • Shehryar Ahmed, MS

    Department of anesthesia Rashid Latif Medical college, Lahore, Pakistan

    PRINCIPAL INVESTIGATOR
  • Syed Shakeel Ahmed, FCPS

    Department of Anesthesia, Shahida Islam Teaching Hospital, Lodhran, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 15, 2024

Study Start

January 1, 2024

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations