ClinicalTrials.gg
RecruitingNCT06346561Updated Apr 4, 2024

The Efficacy of Dexmedetomidine Versus Labetalol In Providing Controlled Hypotension In Dacryocystorhinostomy SurgeryA Comparative Randomized Prospective Study

An interventional study of Dexmedetomidine and Labetalol in Nasolacrimal Duct Obstruction, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as recruiting.

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Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The most important symptoms of nasolacrimal duct obstruction are excessive tearing and mucoid discharge.

The proposed treatment in this regard is dacryocystorhinostomy (DCR) surgery. Therefore, hemostasis is of great significance in performing DCR surgery. In this regard, the reduction of controlled hypotension and the control of hemodynamic responses of the body to stress effectively reduce the bleeding volume during surgery.

Hence, there is no enough studies about controlled hypotension in DCR we decided to perform such a comparison between the effect of dexmedetomidine and labetalol in providing controlled hypotension during DCR surgery.

02

Conditions studied

  • Nasolacrimal Duct Obstruction
03

In context

Lacrimal Duct Obstruction

41 studies on the registry are indexed under Lacrimal Duct Obstruction; 8 are open to participants now.

This study's planned enrollment of 50 is below the median of 75 across 30 interventional studies indexed under Lacrimal Duct Obstruction.

Browse Lacrimal Duct Obstruction studies →

Lead sponsor

Sohag University is the lead sponsor of 1,232 studies on the registry; 638 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • physical status I or II according to , age between ( 18 - 60 years )

Exclusion criteria

Exclusion Criteria:

  • Patients with physical status other than 1 and 2 according to as :Hypertension, Diabetes mellitus, Ischemic heart diseases, Severe anemia, , History of stroke, Impaired liver or renal function, Increase intercranial tension.
  • Allergy to any of the drug included in this study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Dexmedetomidine group

    Drug: Dexmedetomidine · Drug: Labetalol

  • Active comparator
    Labetalol group

    Drug: Dexmedetomidine · Drug: Labetalol

Interventions

  • the reduction of controlled hypotension and the control of hemodynamic responses of the body

  • the reduction of controlled hypotension and the control of hemodynamic responses of the body

06

What researchers measure

Primary outcomes

  1. Assess non invasive blood pressure during DCR surgery To compare between the effect of dexmedetomidine and labetalol in providing controlled hypotension.

    Controlled Hypotension In Dacryocystorhinostomy Surgery By: Dexmedetomidine is a potent α2 adrenergic agonist. Labetalol is a beta-adrenergic blocker agent with alpha1 and beta-adrenergic receptors blocking action

    Time frame: 5 months

Secondary outcomes

  1. Effectiveness of dexamedetomidine for prolongation of postoperative analgesia.

    Dexmedetomidine is a potent α2 adrenergic agonist. One of the highest densities of α2 receptors is located in the pontine locus cereleus, an important nucleus mediating sympathetic nervous system function. It has sedative, anxiolytic, hypnotic, analgesic, and sympatholytic properties.

    Time frame: 5 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Vinciguerra A, Nonis A, Resti AG, Bussi M, Trimarchi M. Impact of Post-Surgical Therapies on Endoscopic and External Dacryocystorhinostomy: Systematic Review and Meta-Analysis. Am J Rhinol Allergy. 2020 Nov;34(6):846-856. doi: 10.1177/1945892420945218. Epub 2020 Jul 23. PubMed 32703027 ↗
  • Heindl LM, Junemann AG, Kruse FE, Holbach LM. Tumors of the lacrimal drainage system. Orbit. 2010 Oct;29(5):298-306. doi: 10.3109/01676830.2010.492887. PubMed 20958177 ↗
  • Degoute CS, Dubreuil C, Ray MJ, Guitton J, Manchon M, Banssillon V, Saumet JL. Effects of posture, hypotension and locally applied vasoconstriction on the middle ear microcirculation in anaesthetized humans. Eur J Appl Physiol Occup Physiol. 1994;69(5):414-20. doi: 10.1007/BF00865405. PubMed 7875138 ↗
  • Alicandri-Ciufelli M, Pingani L, Maccarrone F, Anschuetz L, Mariano D, Galeazzi GM, Presutti L, Molinari G. Validation of the Modena bleeding score in endoscopic sinus surgery. Braz J Otorhinolaryngol. 2022 Jul-Aug;88(4):602-606. doi: 10.1016/j.bjorl.2020.08.006. Epub 2020 Sep 30. PubMed 33279423 ↗
  • Rahimzadeh P, Faiz SH, Alebouyeh MR. Effects of premedication with metoprolol on bleeding and induced hypotension in nasal surgery. Anesth Pain Med. 2012 Winter;1(3):157-61. doi: 10.5812/kowsar.22287523.3408. Epub 2012 Jan 1. PubMed 24904785 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2024; primary completion for Aug 2024, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2024
First posted
Apr 4, 2024
StartEst.
Mar 30, 2024
Primary completionEst.
Aug 30, 2024
CompletionEst.
Aug 30, 2024
Last update
Apr 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06346561
Lead sponsor
Sohag University
Responsible party
Mohamed Aboesoud Mahmoud (Resident of Anesthesia, Intensive Care and Pain management Sohag university hospital., Sohag University) — Principal investigator
First posted
Apr 4, 2024
Start date
Mar 30, 2024 (estimated)
Primary completion
Aug 30, 2024 (estimated)
Completion
Aug 30, 2024 (estimated)
Last update
Apr 4, 2024

Study contacts

Mohammad A Mahmoud, Resident
Contact
mohamedaboelsoad@med.sohag.edu.eg
01090684862
Elhadad A Mousa, Professor
Contact
01019816967

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Dexmedetomidine · Labetalol

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