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We are opted to study that the drug gabapentin is how much safe and effective to prevent or control anxiety pain and fluctuations of blood pressure heart rate and oxygen saturation in blood of patients undergoing eye surgery like vitrectomy procedure a type of eye surgery.

Safety and efficacy of oral Gabapentin in perioperative care of patients undergoing vitrectomy procedures-A randomized control trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/063005
Enrollment
80
Registered
2024-02-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H338- Other retinal detachments Health Condition 2: H358- Other specified retinal disorders Health Condition 3: H330- Retinal detachment with retinal break Health Condition 4: H356- Retinal hemorrhage Health Condition 5: H357- Separation of retinal layers Health Condition 6: H332- Serous retinal detachment Health Condition 7: H334- Traction detachment of retina Health Condition 8: H439- Unspecified disorder of vitreous body Health Condition 9: H359- Unspecified retinal disord

Interventions

Intervention1: Gabapentin: Two doses each of 300 mg of oral Gabapentin first dose at night prior to the day of surgery and second dose in the morning on the day of surgery Intervention2: Placebo: Two

Sponsors

Sankara Eye Hospital Shimoga
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient undergoing vitrectomy at Sankara eye hospital Shimoga. Patients with age group of 18 to 70 years. Patients willing to provide written consent. Patient with known systemic hypertension. Patients who are not consume alcohol for last 3 days.

Exclusion criteria

Exclusion criteria: Patient not willing to give consent. Patients with kidney disease. Patients with known allergy to drug. Patients with known intolerance to this drug. Patients who are on long term medication with anxiolytics sedatives hypnotics anticonvulsants antidepressants or medications for alcohol dependence. Pregnancy and Breastfeeding females. Vitrectomy under general anesthesia and Vitrectomy in Phacoemulsification Patients consuming NSAID or seeking other pain-relieving treatment for more than a month. Patients with no systemic hypertension.

Design outcomes

Primary

MeasureTime frame
Decrease in anxiety in preoperative and postoperative condition. Decrease intraoperative pain. Control intraoperative rise in blood pressure Control intraoperative rise in heart rate Control intraoperative fluctuations in SPO2 level.Timepoint: Preoperative intraoperative and postoperative.—

Secondary

MeasureTime frame
Decrease in surgical duration and better postoperative outcome.Timepoint: Intraoperative and postoperative.—

Countries

India

Contacts

Public ContactDr Niteshkumar Rathor

Sankara Eye Hospital

drravshan@gmail.com09880312124

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026