Deep sedation for ERCP

EARLY COGNITIVE FUNCTION AND RECOVERY AFTER DEXMEDETOMIDINE PROPOFOL OR KETAMINE PROPOFOL FOR DEEP SEDATION IN ERCP

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/09/021445

Enrollment

Registered

2019-09-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.All consenting adult patients with Miniâ??Mental State Examination (MMSE) score greater than or equal to 23. 2.Age-18 to 65 year, either sex 3.ASA Class I to III

Exclusion criteria

Exclusion criteria: 1.Patients unwilling to participate in the study. 2.Known case of psychiatric disorders/ disabling neurological disorder. 4.Addiction to alcohol / substance abuse 5.Miniâ??Mental State Examination (MMSE) less than 23 6.Pregnant and lactating mothers

Design outcomes

Primary

Measure	Time frame
1.To observe the effect of deep sedation on early cognitive recovery after ERCP by the Miniâ?? Mental State Examination (MMSE) and Digit symbol substitution test. 2.To observe the effect of deep sedation on psychomotor recovery after ERCP by Trieger Dot Test. 3.To observe the time taken to achieve Modified Aldrete Score of 9 or more after deep sedation in ERCP. 4.To observe VAS Score for pain after deep sedation in ERCP. Timepoint: 1.Baseline. 3.After Loading Dexmed. 3.After loading ketamine 4.After ERCP 5.Every 30 minutesthereafter.	—

Measure

Time frame

1.To observe the effect of deep sedation on early cognitive recovery after ERCP by the Miniâ?? Mental State Examination (MMSE) and Digit symbol substitution test. 2.To observe the effect of deep sedation on psychomotor recovery after ERCP by Trieger Dot Test. 3.To observe the time taken to achieve Modified Aldrete Score of 9 or more after deep sedation in ERCP. 4.To observe VAS Score for pain after deep sedation in ERCP. Timepoint: 1.Baseline. 3.After Loading Dexmed. 3.After loading ketamine 4.After ERCP 5.Every 30 minutesthereafter.

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Secondary

Measure	Time frame
1.To study the hemodynamic parameters Heart Rate (HR), Systolic and Diastolic Blood Pressure (SBP and DBP), in patients undergoing ERCP under deep sedation. 2.To study the complications occurring during ERCP under deep sedation 3.To study Endoscopist satisfaction score. Timepoint: 1.Baseline. 3.After Loading Dexmed. 3.After loading ketamine 4.After ERCP 5.Every 30 minutesthereafter.	—

Countries

India

Contacts

Public ContactDr Preeti Rustagi

Lokmanya Tilak Muncipal MedicalCollege and General Hospital, Sion, Mumbai

drpreetirustagi@rediffmail.com9769215359

Outcome results