Dexmedetomidine and Pregabalin for Conscious Sedation During Cataract Surgery

Conscious Sedation Clinical Trial

Official title:

Dexmedetomidine With or Without Pregabalin Premedication for Conscious Sedation During Cataract Surgery Under Topical Anesthesia. A Randomized Double-blind Placebo-controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03735368
• Other study ID #: 2018/10/15/5
• Status: Completed
• Phase: Phase 2
• Start date: December 10, 2018
• Est. completion date: November 29, 2019

Study information

• Verified date: December 2019
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although topical anesthesia by eye drops for cataract surgery is a non-invasive technique but it may provide insufficient anesthesia which requires the intraoperative use of additional topical local anesthetics and raises the need for sedation.

Description:

The present study is constructed to evaluate the effect of pregabalin on sedation using dexmedetomidine for cataract surgery under topical anesthesia . In the dexmedetomidine-pregabalin group, the patients will be premedicated by pregabalin. In the placebo group (control group) the patients will be premedicated by placebo capsules. All patients will be sedated by dexmedetomidine. Sedation will be assessed as a primary outcome measurement where pain, vital signs, intraoperative and postoperative pain, total analgesic needs and side effects will be assessed as secondary outcome measurements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 29, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• American Society Of Anesthesiologists (ASA) I and II physical status.

• Scheduled for cataract extraction under topical anesthesia.

Exclusion Criteria:

• Hepatic or renal impairment.

• Taking chronic psychotropic medications.

• Mental instability.

• Morbid obesity.

• Alcohol abuse.

• Substance abuse.

• Pregnant and lactating females.

• History of allergy to the study drugs used

Related Conditions & MeSH terms

• Cataract
• Conscious Sedation

Intervention

Drug:
• Dexmedetomidine Injection
Dexmedetomidine Injection 1 µg/kg then 0.5-1 µg/kg/h infusion
• Placebo oral capsule
placebo oral capsules
• Pregabalin Oral Capsule
150 mg pregabalin Oral Capsule
• topical anesthesia
topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Cairo	Shebin El-kom

Sponsors (1)

Lead Sponsor	Collaborator
Abd-Elazeem Abd-Elhameed Elbakry

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sedation score changes	Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation.	baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Secondary	pain score changes	verbal pain score (VPS) from 0 = no pain to 10= the worst pain imaginable. scor = 3 indicates need of analgesia	baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Secondary	heart rate changes	beats/minute	baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Secondary	arterial blood pressure changes	mmHg	baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Secondary	arterial oxygen saturation	the percentage of hemoglobin saturation with oxygen in arterial blood.	baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Secondary	respiratory rate	breath/minute	baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Secondary	total dexmedetomidine consumption	ug	intraoperatively
Secondary	Incidence of respiratory depression	percentage	from administering premedication till 24 hours postoperative.
Secondary	Incidence of hypotension	percentage	from administering premedication till 24hours postoperative
Secondary	Incidence of bradycardia	percentage	from administering premedication till 24hours postoperative
Secondary	Incidence of ataxia	percentage	from administering premedication till 24hours postoperative