A Comparative Study of Oral Gabapentin, Oral Alprazolam and Intravenous Dexmedetomidine on Perioperative Anxiety and Pain During Posterior Segment Eye Surgery Under Peribulbar Block : a Randomized, Double-blind Study.

Sedation for Patients Undergoing Peribulbar Block Clinical Trial

Official title:

A Comparative Study of Oral Gabapentin, Oral Alprazolam and Intravenous Dexmedetomidine on Perioperative Anxiety and Pain During Posterior Segment Eye Surgery Under Peribulbar Block : a Randomized, Double-blind Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04658732
• Other study ID #: MD-240-2019
• Status: Recruiting
• Phase: Phase 1
• Start date: December 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: December 2020
• Source: Cairo University
• Contact: ismail ahmed ismail, McS
• Phone: 01000844089
• Email: dr.ismail.Gp2014[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We hypothesized that gabapentin when given orally as a premedication in patients who perform posterior segment eye surgery under peribulbar block would provide adequate anxiolysis and arousable sedation as alprazolam and dexmedetomidine with minimal side effects .

Description:

The principle goal of sedation for eye surgery is to prepare the patients to stay calm during surgery. Both insufficient sedation and deep sedation may lead to sudden movements by patients, which may potentially result in harmful complications during eye surgery. Several drugs such as propofol, opioids, and dexmedetomidine have been used for sedation during this procedure [1]. However, each of these drugs has its own limitations, leading to impairment of patient's cooperation during surgery. Therefore, the potential clinical advantages of newly-marketed therapeutic drugs should be thoroughly evaluated. [2] Benzodiazepines are amongst the most popular preoperative medication to produce anxiolysis, amnesia, and sedation for the patients coming for surgery [3]. Benzodiazepines are reported to be paradoxically associated with the increased episodes of arousal during sleep, restlessness, and hangover effects [4]. Alprazolam, a benzodiazepine class of antipsychotic drugs, is more anxioselective than the other premedicants of this group like midazolam, lorazepam, or diazepam [5]. It has also been reported to show arousal episodes and may cause psychomotor impairment which is a disadvantage to be used in elderly in general and in day case in particular [4,6].

Gabapentin is well-tolerated drug that is associated with anxiolytic and antinociceptive properties [2]. It is reported that gabapentin has anxiolytic [7] and antinociceptive effects [8,9]. In another study, it is claimed that this drug does not depress respiration with no effect on gastric mucosa, platelets, and renal function [9]. Moreover, gabapentin seems to be an anxiolytic without amnesic effects which is an important advantage for elderly patients. Leung and colleagues reported that delirium is significantly less in patients receiving gabapentin before spine surgery[10].

Dexmedetomidine, a highly selective α2 agonist, has been widely used as a sedative in a variety of clinical settings owing to its analgesic properties, minimal respiratory depression and easy arousability [11,12].Hypotension and bradycardia, the most frequent side effects of dexmedetomidine [12], occur in a dose-related manner [13,14]. To avoid these side effects, a dose adjustment is required. For procedural sedation, a loading dose of 0.25μg/kg over 10 min followed by maintenance dose of 0.25μg/kg/h provides an adequate level of sedation, stable hemodynamics and better surgeon satisfaction [15].

In this study, we planned to compare the sedative effects of oral gabapentin, alprazolam and intravenous of dexmedetomidine on various parameters including anxiety, sedation and orientation. In our literature review, we could not find any study comparing the effect of gabapentin and alprazolam on anxiety, pain, sedation scores, satisfaction of surgeon, and hemodynamic parameters in posterior segment eye surgery under peribulbar block.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients aged from 45 to 65 years old, of both sexes.

• ASA 1-2.

• Undergo posterior eye surgery (vitrectomy and retinal detachment) under peribulbar block.

Exclusion Criteria:• Patient refusal.

• Uncooperative patient.

• Communication difficulty resulting from deafness or language barrier.

• Chronic use of narcotics, barbiturate, psychotropic medications or claustrophobia.

• Body weight less than 40 kg or more than 100 kg.

• Known allergy to local anesthetics or any of the study drugs.

• ASA 3-4.

• Inability to lie supine for the time of surgery or involuntary movement.

• Patients with baseline heart rate (HR) <60/min, severe left ventricular dysfunction (EF <30%), hypovolaemia with systolic blood pressure (SBP) <90 mmHg, Mobitz type 2 or 3rd degree heart block, severe valvular disease (valve stenosis/regurgitation), asthma, chronic cough, upper respiratory tract infection within the previous 2 weeks, chronic renal failure and hepatic impairment will be excluded from the study.

• Patients on medications can affect the removal of alprazolam from the body, which may affect how alprazolam works. Examples include azole antifungals (such as itraconazole, ketoconazole),cimetidine, certain antidepressants (such as fluoxetine, fluvoxamine, nefazodone ),drugs to treat HIV( delavirdine, protease inhibitors such as indinavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St.John's Wort and drugs used to treat seizures (such as phenytoin).

• Patients with myasthenia gravis or myoclonus problems.

Related Conditions & MeSH terms

• Sedation for Patients Undergoing Peribulbar Block

Intervention

Drug:
• Administration of Alprazolam , Gabapentin , Dexmedetomidine
Patients will be allocated into one of the 3 groups: Alprazolam (A group), Gabapentin (G group) and Dexmedetomidine (D group) as control group. Alprazolam group (n=15): patients in this group will receive 0.25 mg Alprazolam (2 tablets of Xanax 0.125 mg manufactured by Pfizer). Gabapentin group (n=15): patients in this group will receive 600mg Gabapentin (2 capsules of Neurontin 300 mg manufactured by Pfizer).Control group (n=15): patients in this group will receive 2 tablets of multivitamin (Vitamax manufactured by GlaxoSmithKline S.A.E) as placebo to ensure blindness of the study. The study drug will be received 120 minutes before the operation.

Locations

Country	Name	City	State
Egypt	Kasr Al Ainy School of Medicine	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ehab Tarek Fahmy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary outcome	The sedation level of patients using Ramsay sedation scale (RSS) [19] during surgery will be assessed every 5 min for the first 15 min (5, 10, 15), every 15 min until the end of surgery and every 30 min for 2 h in the post-operative ward.	intraoperative and 2 hours postoperative . along time of the study
Secondary	Secondary outcome	• The verbal pain score (VPS) ranging from 0 to10 (0 = no pain and 10 = worst pain imaginable) will be fully explained to patients	intraoperative and 2 hours postoperative . along time of the study