NCT05298761

Brief Summary

Comparison of I/V nalbuphine versus I/V xylocain in attanuation of pressor response during intubation and laryngeoscopy in patients undergoing for thyroid surgery,selection of better supressor agent minimises the drug repated side effects like hypertention tachycardia but also helps in heamodynamically stability at induction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

February 22, 2022

Last Update Submit

November 20, 2023

Conditions

Hemodynamic Stability

Outcome Measures

Primary Outcomes (2)

  • Reduce stress response during intubation and hemodynamic stabilty

    Assesment of Hemodynamic stability by observing vital signs

    10 minutes

  • Achieve hemodynamic stabilty and smooth intubation

    Assesment of hemodynamic stability by clinical examination of vital signs

    10 minutes

Study Arms (2)

Lignocain

EXPERIMENTAL

I/V lignocain 1.5mg per kg given to participants in state dose

Drug: Lignocaine

nalbuphine

EXPERIMENTAL

I/v nalbuphine 0.1mg per kg given to participants in stat dose

Drug: Lignocaine

Interventions

LignocaineDRUG

Inj lignocain and inj nalbuphine given to two groups of participants and effects of both drugs

Also known as: Nalbuphine
Lignocainnalbuphine

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • middle age(18\_40)
  • Asa 1 and 2
  • Non hypertensive
  • Thyroid patients
  • patient who gives consent

You may not qualify if:

  • hypertensive
  • Asa 3 and 4
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr.amna

Rahim Yar Khan, Punjab Province, 092, Pakistan

Location

MeSH Terms

Interventions

LidocaineNalbuphine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Dr.amna Sarwar, Fcps

    Sheikh zaied medical hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.amna Sarwar, Fcps

CONTACT

03218337129Dr.amnasabir@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 22, 2022

First Posted

March 28, 2022

Study Start

December 30, 2023

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)