The Effect of Esmolol Versus Dexmedetomidine on Postoperative Pain Control in Endoscopic Sinus Surgery: A Randomized Trial

NCT05703048 | Unknown

• 1 other identifier: esmolol versus dexmedetomidine
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Hypotensive techniques are associated with certain disadvantages. Hence, anesthesiologists are still in search of drugs with fewer side effects. Various drugs such as high-concentration volatile anesthetics, magnesium sulfate, remifentanil, clonidine, calcium channel blockers, tranexamic acid, intravenous nitroglycerin, and sodium nitroprusside have been evaluated to control blood pressure and decrease blood loss during surgery, thereby improving the surgical field quality. Opioids are the mainstay of treatment for perioperative pain, but their administration increases the incidence of respiratory complications, slows down normal gastrointestinal motility, and prolongs hospital stay. With the development of enhanced recovery after surgery (ERAS), reducing the use of opioids in the perioperative period has become the common goal of anesthesiologists. The dosage of opioids should be strictly controlled whenever possible, which should not only meet the needs of analgesia perioperatively, but also minimize the incidence of adverse reactions. Opioid-free anesthesia (OFA) represents a step forward in anesthetic practice as it potentially spares the use of opioids by administrating nonopioid agents and adjuncts. The rationale to propose OFA is based on the aim to avoid the negative impact of intraoperative opioids on a patient's postoperative outcomes. Several studies showed that β adrenergic receptor antagonists withhold the upsurge of catecholamines circulating in blood which induced by surgery, as well as having analgesic sparing effect itself. Esmolol is an ultrashort acting β1 blocking drug that has been uncovered to own opioid-sparing effects likely due to resemblances in its structure with local anesthetic agents. Esmolol's short course of action and titrability offer it as an attractive drug to use, although the mechanism of action of its analgesic effect has yet to be established. Dexmedetomidine hydrochloride is a specific alpha-2 adrenoreceptor agonist that has intrinsic analgesic and sedative properties coupled with anxiolytic and sympatholytic effects. It minimizes the hemodynamic and neuroendocrine responses to anesthesia and surgery by suppressing the sympathetic tone. This hemodynamic stability can improve the surgical outcome as well as both patient and surgeon satisfaction. Dexmedetomidine accompanied by other anesthetics causes a controlled reduction in blood pressure and heart rate and improves the quality of the surgical field. Alpha-2 adrenergic agonists (dexmedetomidine) have pharmacologic characteristics (sedation, hypnosis, anxiolysis, sympatholytic, and analgesia) that make them suitable as adjuvants to multimodal analgesia. Their anti-nociceptive effect is attributed to the stimulation of a2- adrenoceptors located in the central nervous system. Dexmedetomidine is a highly selective and potent a2-adrenoceptor agonist. Its intrathecal administration leads to anti-nociceptive effects, although it does have some undesired side effects (e.g., hypotension, bradycardia, and sedation).

Conditions

Patient's Satisfaction; Depth of Anesthesia

Keywords

postoperative pain; emergence of aneasthesia

Outcome Measures

Primary Outcomes (1)

• opioid (morphine) consumption up to 24 hours after end of the surgery.

  opioid (morphine) consumption up to 24 hours after end of the surgery.

  first 24 hs following surgery.

Secondary Outcomes (5)

• visual analog scale (VAS) score for pain ( maximum score was 10 which mean sever pain and least score was 0 which mean no pain)

  in the PACU at admission

• visual analog scale (VAS) score for pain ( maximum score was 10 which mean sever pain and least score was 0 which mean no pain)

  in the PACU at one hour postoperative

• visual analog scale (VAS) score for pain ( maximum score was 10 which mean sever pain and least score was 0 which mean no pain)

  in the PACU at 6 hours in surgical ward

• visual analog scale (VAS) score for pain ( maximum score was 10 which mean sever pain and least score was 0 which mean no pain)

  in the PACU at 12 hours in surgical ward

• visual analog scale (VAS) score for pain ( maximum score was 10 which mean sever pain and least score was 0 which mean no pain)

  in the PACU at 24 hours in surgical ward

Study Arms (2)

dexmedetomidine group

EXPERIMENTAL

35 patients will be received dexmedetomidine (Precedex; Abbott Laboratories, North Chicago, Illinois, USA) (vial = 2 ml) 100 mcg/ml at bolus dose of 1 mcg /kg slowly infused over 10 min, then continuous infusion by a rate of 0. 5 mcg /kg/h., infused by a syringe pump. infusion stopped immediately upon extubation.

Drug: Dexmedetomidine

Esmolol group

ACTIVE COMPARATOR

35 patients will be received i.v. received a loading dose of esmolol 0.5 mg/kg in 30 mL isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min. infusion stopped immediately upon extubation.

Drug: Esmolol Esterase

Interventions

Esmolol Esterase DRUG

35 patients will be received i.v. received a loading dose of esmolol 0.5 mg/kg in 30 mL isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min. infusion stopped immediately upon extubation.

Also known as: Esmolol

Esmolol group

Dexmedetomidine DRUG

35 patients will be received dexmedetomidine (Precedex; Abbott Laboratories, North Chicago, Illinois, USA) (vial = 2 ml) 100 mcg/ml at bolus dose of 1 mcg /kg slowly infused over 10 min, then continuous infusion by a rate of 0. 5 mcg /kg/h., infused by a syringe pump. infusion stopped immediately upon extubation.

dexmedetomidine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with American Society of Anesthesiologists (ASA) Physical Status Class I\&II, aged \> 18 years. and scheduled for FESS.

You may not qualify if:

• \. The patients on β-blockers and cardiovascular active drugs 2. History of neuromuscular disorder, diabetic neuropathy, pregnancy 3. Prolonged QT interval and ventricular arrhythmia, specifically a pre-disposition to bradycardia or conduction abnormalities, cyanotic cardiac disease, and use of medications that would increase the risk of bradycardia.
• \. Current (Within the last 30 days) opioid use for pain control as sickle cell disease, substance abuse or benzodiazepine addiction 5. History of end stage hepatic, renal, diabetes mellitus, and bleeding disorders, 6. Allergy and hypersensitivity to the drugs used in the study 7. Excessive use of analgesics/non-steroidal anti-inflammatory drugs 8. Morbid obesity (body mass index (BMI) \> 40) 9. A positive history of motion sickness, women who had a history of nausea and vomiting before menstruation.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine, Tantan University Hospital

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

esmolol esterase; esmolol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

amany omara, professor

CONTACT

+201008372249; amanyfaheem2011@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A computer system will be used for randomization by creating a list of number each number referred to one of the two groups. Block randomization will be used to ensure equality of the groups. Each number will be sealed in an opaque envelope. Then, each patient will be asked to choose one of the envelopes and give it to an anesthesiologist who compared it to the computer-generated list and hence assigned her to one of the two groups. The anesthesiologist, participant and outcomes Assessor will be blinded to the collected data until the end of the study and administered the medication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anesthesiology, intensive care, and pain medicine

Model Details: In group A (dexmedetomidine group): 35 patients will be received dexmedetomidine (Precedex; Abbott Laboratories, North Chicago, Illinois, USA) (vial = 2 ml) 100 mcg/ml at bolus dose of 1 mcg /kg slowly infused over 10 min, then continuous infusion by a rate of 0. 5 mcg /kg/h., infused by a syringe pump. infusion stopped immediately upon extubation. In group B (Esmolol group): 35 patients will be received i.v. received a loading dose of esmolol 0.5 mg/kg in 30 mL isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min. infusion stopped immediately upon extubation.

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 27, 2023
• Study Start: December 30, 2022
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)