NCT04356196

Brief Summary

The study aims to compare the effect of addition of verapamil and Bisoprolol to general anasthesia aimed reduction in heart rate and blood loss during endoscopic sinus surgery.

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
135

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

April 18, 2020

Last Update Submit

November 21, 2021

Conditions

Endoscopic Sinus SurgeryHeart RateBlood Loss

Outcome Measures

Primary Outcomes (2)

  • Heart Rate

    heart beats for minutes

    intraoperative

  • Estimated Blood Loss

    Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery dividing by surgical time in hours.

    end of operation assessment

Secondary Outcomes (3)

  • The Boezaart and van der Merwe intraoperative surgical field scale

    Every 15 minutes for the duration of surgery

  • plasma norepinephrine concentrations

    baseline before Anastasia ( in the holding area with insertion of I.V. cannula) and three hours after the end of surgery.

  • serum cortisol concentrations

    baseline before Anastasia ( in the holding area with insertion of I.V. cannula) and three hours after the end of surgery.

Study Arms (3)

Verapamil group

EXPERIMENTAL

45 patients will receive 80 mg oral verapamil 3 hours pre-operative

Drug: Verapamil

Bisoprolol group

EXPERIMENTAL

45 patients will receive Bisoprolol 5mg PO 3 hours preoperative

Drug: Bisoprolol

placebo group

EXPERIMENTAL

45 patients will receive placebo tablet PO 3 hours preoperative .

Drug: Placebo oral tablet

Interventions

VerapamilDRUG

Verapamil is a phenylalkylamine calcium channel blocker used in the treatment of high blood pressure, heart arrhythmias, and angina

Also known as: Isoptin
Verapamil group
BisoprololDRUG

Bisoprolol is a cardioselective β1-adrenergic blocking agent used to treat high blood pressure.

Also known as: concor
Bisoprolol group
Placebo oral tabletDRUG

Placebo oral tablet

placebo group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age of 18 - 60 years.
  • patients of both genders.
  • ASA grade I - II.

You may not qualify if:

  • Patient refusal.
  • Any contraindication of B- blocker:
  • Athma , COPD
  • Bradycardia , Heart block
  • Acute decompensated heart failure
  • Peripheral vascular disease
  • Any contraindication of calcium channel blocker:
  • AV conduction defects (2nd and 3rd degree AV block).
  • Sick sinus syndrome .
  • Wolf-Parkinson-White Syndrome.
  • History of congestive heart failure.
  • Patients on long-term ß-blocker therapy.
  • Patients with allergy to medication included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Assiut university

Asyut, Egypt

Location

Related Publications (9)

  • Thongrong C, Kasemsiri P, Carrau RL, Bergese SD. Control of bleeding in endoscopic skull base surgery: current concepts to improve hemostasis. ISRN Surg. 2013 Jun 13;2013:191543. doi: 10.1155/2013/191543. Print 2013.

    PMID: 23844295BACKGROUND

  • Hadad G, Bassagasteguy L, Carrau RL, Mataza JC, Kassam A, Snyderman CH, Mintz A. A novel reconstructive technique after endoscopic expanded endonasal approaches: vascular pedicle nasoseptal flap. Laryngoscope. 2006 Oct;116(10):1882-6. doi: 10.1097/01.mlg.0000234933.37779.e4.

    PMID: 17003708BACKGROUND

  • Stammberger H. Endoscopic endonasal surgery--concepts in treatment of recurring rhinosinusitis. Part II. Surgical technique. Otolaryngol Head Neck Surg. 1986 Feb;94(2):147-56. doi: 10.1177/019459988609400203.

    PMID: 3083327BACKGROUND

  • Stankiewicz JA, Lal D, Connor M, Welch K. Complications in endoscopic sinus surgery for chronic rhinosinusitis: a 25-year experience. Laryngoscope. 2011 Dec;121(12):2684-701. doi: 10.1002/lary.21446. Epub 2011 Nov 15.

    PMID: 22086769BACKGROUND

  • Eberhart LH, Folz BJ, Wulf H, Geldner G. Intravenous anesthesia provides optimal surgical conditions during microscopic and endoscopic sinus surgery. Laryngoscope. 2003 Aug;113(8):1369-73. doi: 10.1097/00005537-200308000-00019.

    PMID: 12897561BACKGROUND

  • Ankichetty SP, Ponniah M, Cherian V, Thomas S, Kumar K, Jeslin L, Jeyasheela K, Malhotra N. Comparison of total intravenous anesthesia using propofol and inhalational anesthesia using isoflurane for controlled hypotension in functional endoscopic sinus surgery. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):328-32. doi: 10.4103/0970-9185.83675.

    PMID: 21897501BACKGROUND

  • Degoute CS, Ray MJ, Manchon M, Dubreuil C, Banssillon V. Remifentanil and controlled hypotension; comparison with nitroprusside or esmolol during tympanoplasty. Can J Anaesth. 2001 Jan;48(1):20-7. doi: 10.1007/BF03019809.

    PMID: 11212044BACKGROUND

  • Tobias JD. Controlled hypotension in children: a critical review of available agents. Paediatr Drugs. 2002;4(7):439-53. doi: 10.2165/00128072-200204070-00003.

    PMID: 12083972BACKGROUND

  • Degoute CS. Controlled hypotension: a guide to drug choice. Drugs. 2007;67(7):1053-76. doi: 10.2165/00003495-200767070-00007.

    PMID: 17488147BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

VerapamilBisoprolol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic ChemicalsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsPropanols

Study Officials

  • Mohammed Sayed Hassanein

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 18, 2020

First Posted

April 22, 2020

Study Start

June 15, 2021

Primary Completion

December 28, 2021

Study Completion

December 30, 2021

Last Updated

December 3, 2021

Record last verified: 2021-11

Locations

EG(1)