Dexmedetomidine Versus Nitroglycerin on Surgical Field Quality and Drug Cost in Functional Endoscopic Sinus Surgeries

NCT07585201 | Completed

• 1 other identifier: ZU-IRB #9667
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Sinus surgery is one of the most prevalent ear, nose, and throat (ENT) surgeries, which is mainly carried out nowadays through functional endoscopic sinus surgery (FESS) and leads to significant improvement in the clinical symptoms of patients with rhinosinusitis. It is necessary to maintain safe conditions for this surgery, and the major problem reported during FESS under general anesthesia (GA) is impaired visibility due to excessive amount of bleeding. This is particularly important for the successful surgery of the ethmoid and sphenoid sinuses because even minimum amount of bleeding might seriously impair the successful completion of the surgery, increase the operational risk, and increase surgery time which are major concerns for both anesthesiologist and ENT specialist. Controlled hypotension is the commonly used technique to limit blood loss and improve visualization in the surgical field during FESS, various techniques have been adopted to achieve controlled hypotension, one of them is the use of pharmacological drugs in the form of volatile anesthetics, direct-acting vasodilators, autonomic ganglion-blockers, and α-adrenergic receptor blockers. Alpha-2 (α-2) receptors are found in the peripheral and central nervous systems, platelets and many other organs including the liver, pancreas, kidney, and eye. Stimulation of the receptors in the brain and spinal cord inhibits neuronal firing causing hypotension, bradycardia, sedation, and analgesia. Alpha-2 (α-2) agonist drugs have sympatholytic, sedative, anesthetic, and analgesic sparing effects, as well as vasoconstrictive effects and thereby reduce intraoperative bleeding. Also, the use of α-2 agonists in the perioperative period has been associated with reduced anesthetic requirements, decreased heart rate and blood pressure. Dexmedetomidine is a highly selective α-2 adrenergic receptor agonist (selectivity ratio for α2: α1 is 1600:1). The sympatholytic effect of dexmedetomidine made it attractive to be used as a hypotensive drug during surgery because of decreasing heart rate (HR) and cardiac output (CO) without decreasing stroke volume unless the plasma concentrates reaches above 5.1 μg/mL. The cardiovascular effects of dexmedetomidine begin with initial hypertension following the administration of a loading dose, due to the activation of α 2B receptors located on vascular smooth muscle, with subsequent hypotension and bradycardia due to centrally mediated decrease in sympathetic tone. Dexmedetomidine also has sedative, amnesic, anxiolytic, hypnotic, and analgesic effects with minimal changes in respiratory variables. Furthermore, it reduces postoperative nausea, vomiting, and shivering. It also reduces delirium in patients after cardiac surgery. Nitroglycerin is a directly acting vasodilator drug frequently used to produce controlled hypotension because it is easily titratable and having very rapid onset as well as rapid offset of action. However, the disadvantages of nitroglycerin are reflex tachycardia and venous congestion which leads to increased blood loss. Aim of the work was improving surgical field quality and drug cost in patients undergoing Functional Endoscopic Sinus Surgeries by comparing between dexmedetomidine and nitroglycerin.

Conditions

Hypotension; Intraoperative Bleeding; Functional Endoscopic Sinus Surgeries

Keywords

Dexamedomidine; Nitroglycerin; Controlled Hypotension; Functional Endoscopic Sinus Surgeries

Outcome Measures

Primary Outcomes (2)

• The quality of the surgical field

  The visibility of the surgical field was assessed by surgeon using Fromme and Boezaart scoring system: 0 No bleeding (cadaveric conditions) I Slight bleeding, no suctioning required II Slight bleeding, occasional suctioning required III Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed IV Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed V Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible

  perioperative

• Drug cost

  estimate and compare the drug cost in both groups by Egyptian pounds

  perioperative

Secondary Outcomes (5)

• Emergence time

  perioperative

• Mean arterial pressure

  basal, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes

• Heart rate

  basal, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes , 120 minutes

• Recovery time

  perioperative

• Complications

  perioperative

Study Arms (2)

Group D

ACTIVE COMPARATOR

dexmedetomidine as controlled hypotensive drug

Drug: controlled hypotension using dexmedetomidine

Group N

ACTIVE COMPARATOR

Nitroglycerin as controlled hypotensive drug

Drug: controlled hypotension hypotension using nitroglycerin

Interventions

controlled hypotension using dexmedetomidine DRUG

Started infusion of a loading dose of dexmedetomidine 1 μg /kg over 10 minutes before induction of anesthesia. Induction: Fentanyl IV (2 μg/kg), Propofol IV (2 mg/kg), and Rocuronium IV (1mg/kg). Maintenance: Maintenance of anesthesia was done with isoflurane inhalation at 1-2 minimum alveolar concentration (MAC) and incremental doses of rocuronium 0.5mg/kg every 45 minutes. IV infusion of dexmedetomidine 0.3-0.7 µg/kg/h. Dexmedetomidine was titrated till mean arterial pressure (MAP) 60-70 mmHg, or a MAP below 30% of baseline.

Group D

controlled hypotension hypotension using nitroglycerin DRUG

Induction: • Fentanyl IV (2 μg/kg), Propofol IV (2 mg/kg), and Rocuronium IV (1 mg/kg). Maintenance: * Maintenance of anesthesia was done with isoflurane inhalation at 1-2 (MAC) and incremental doses of rocuronium 0.5 mg/kg every 45 minutes. * IV infusion of nitroglycerin at a dose of 0.5-2 µg/kg/min. Nitorglycerin) was titrated till mean arterial pressure (MAP) 60-70 mmHg, or a MAP below 30% of baseline.

Group N

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physical status: American Society of Anesthesiologists (ASA) I \& II.
• Body Mass Index (BMI): 18.5-30 kg/m2.
• Type of operation: elective bilateral FESS.
• Type of anesthesia: general anesthesia.

You may not qualify if:

• Patients with known history of allergy to study drugs.
• Anticipated difficult intubation.
• Advanced hepatic, renal or cardiovascular diseases.
• Central nervous system disorder, metabolic disease, and electrolyte imbalance.
• Coagulopathies or taking drugs affecting coagulation.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university

Zagazig, Sharqia Province, 44111, Egypt

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Hypotension

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 13, 2026
• Study Start: September 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 1, 2023
• Last Updated: May 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)