Efficacy of Oral Verapamil and Oral Diltiazim on Reduction of Intraoperative Bleeding During Endoscopic Sinus Surgery Under General Anesthesia

NCT04790331 | Unknown Early Phase 1

• 1 other identifier: Verapamil andDiltiazim in ESS
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

To study the effect of addition of oral verapamil or Diltiazim to general anaesthesia on the Intraoperative haemodynamics : heart rate(HR), noninvasive blood pressure(NIBP), mean arterial blood pressure(MAP), and the blood loss during endoscopic sinus surgery.

Conditions

Verapamil; Diltiazim; FESS

Outcome Measures

Primary Outcomes (2)

• heart rate

  heart beats for minutes

  for the duration of surgery up to 2 hours

• 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.

  for the duration of surgery up to 2 hours

Secondary Outcomes (3)

• The Boezaart and van der Merwe intraoperative surgical field scale.

  for the duration of surgery up to 2 hours

• plasma norepinephrine concentrations

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

• serum cortisol concentrations

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

Study Arms (3)

verapamil group

EXPERIMENTAL

verapamil group who will receive verapamil 80 mg PO 3 hours preoperative

Drug: Verapamil

Ditiazim

EXPERIMENTAL

Diltiazim group will receive Diltiazim 90mg PO 3 hours preoperative

Drug: Diltiazem

placebo group

EXPERIMENTAL

Placebo oral tablet

Drug: Placebo

Interventions

Verapamil DRUG

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

Diltiazem DRUG

Diltiazem is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels. Diltiazem is used to treat hypertension and angina.

Ditiazim

Placebo DRUG

Placebo oral tablet

placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.

Sponsors & Collaborators

• Assiut University: lead

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: 23844295 BACKGROUND

• 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: 17003708 BACKGROUND

• 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: 3083327 BACKGROUND

• 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: 22086769 BACKGROUND

• 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: 12897561 BACKGROUND

• 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: 21897501 BACKGROUND

• 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: 11212044 BACKGROUND

• 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: 12083972 BACKGROUND

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

  PMID: 17488147 BACKGROUND

MeSH Terms

Interventions

Verapamil; Diltiazem

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Peter Maher Zaki Habeeb

CONTACT

00201068058088; pmaher1975@gmail.com

Study Design

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

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 10, 2021
• Study Start: March 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 20, 2022
• Last Updated: March 10, 2021

Record last verified: 2021-03