Dexmedetomidine vs. Ketorolac/ Midazolam for Retinal Surgery

NCT03143244 | Completed Phase 4 DMC

• 1 other identifier: MS/15.12.26
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate and compare the effect of administration of intravenous ketorolac- midazolam or dexmedetomidine as adjuvants to general anesthesia on perioperative outcome during retinal surgery.

Conditions

Retinal Surgery

Outcome Measures

Primary Outcomes (2)

• Changes in blood pressure

  Blood pressure measurements were performed electronically

  for 8 hours after start of surgery

• Changes in heart rate

  Heart rate measurements were performed electronically

  for 8 hours after start of surgery

Secondary Outcomes (4)

• Intra-ocular pressure

  for 8 hours after start of surgery

• Occurrence of Oculao-cardiac reflex

  for 14 hours after start of surgery

• Postoperative nausea or vomiting

  for 24 hours after start of surgery

• Postoperative pain score

  for 24 hours after start of surgery

Study Arms (3)

Dexmedetomidine group (D)

ACTIVE COMPARATOR

Patients received 1ug/kg dexmedetomidine in 50 ml saline over 10 min i.v 30 min before induction then 0.4 ug/kg/h dexmedetomidine (4ug/ml) and normal saline 0.1 ml/kg till end of surgery, using two syringe pumps one for dexmedetomidine and the other for saline

Drug: Dexmedetomidine group (D)

Ketorolac-Midazolam group (KM)

ACTIVE COMPARATOR

Patients received 0.5mg/kg ketolac in 50 ml saline over 10 min before induction and 25ug/kg midazolam in 50 ml saline over 10 min i.v 30 min before induction then 50ug/kg/h of ketolac and 40ug/kg/h midazolam till end of surgery in two separate syringe pumps.

Drug: Ketorolac-Midazolam group (KM)

Control group (Normal Saline) (C)

PLACEBO COMPARATOR

Patients received same volume of normal slaine in two sets.

Drug: Control group (Normal Saline) (C)

Interventions

Dexmedetomidine group (D) DRUG

Patients received 1ug/kg dexmedetomidine in 50 ml saline over 10 min i.v 30 min before induction then 0.4 ug/kg/h dexmedetomidine (4ug/ml) and normal saline 0.1 ml/kg till end of surgery, using two syringe pumps one for dexmedetomidine and the other for saline

Dexmedetomidine group (D)

Ketorolac-Midazolam group (KM) DRUG

Patients received 0.5mg/kg ketolac in 50 ml saline over 10 min before induction and 25ug/kg midazolam in 50 ml saline over 10 min i.v 30 min before induction then 50ug/kg/h of ketolac and 40ug/kg/h midazolam till end of surgery in two separate syringe pumps.

Ketorolac-Midazolam group (KM)

Control group (Normal Saline) (C) DRUG

Patients received normal saline in two sets

Control group (Normal Saline) (C)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status \|or \|\|

You may not qualify if:

• Mental disorders.
• Psychological disorders.
• Neurological disorders.
• Hyper reactive airway disease.
• History of sleep apnoea.
• Severe cardiovascular disease.
• Respiratory disease.
• Hepatic disease.
• Renal impairment.
• Known sensitivity to any of study drugs.
• History of alcohol.
• History of drug abuse.
• Morbid obesity (body mass index \>35).
• Pregnancy.
• Lactating women.

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Interventions

Fumigant 93; Control Groups; Saline Solution

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Enas A Abd el Motlb, MD

  Assisitant Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2017
• First Posted: May 8, 2017
• Study Start: January 1, 2016
• Primary Completion: November 29, 2016
• Study Completion: November 30, 2016
• Last Updated: May 8, 2017

Record last verified: 2017-05