Reduction in total requirement of opioid by using intravenous Ketamine infusion in very low doses for pain control after free flap reconstruction for oral defects.
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynxHealth Condition 2: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2020/09/028057
- Lead Sponsor
- TMC trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
The subject has a histologically confirmed squamous cell carcinoma of the oral cavity
The subjects age must be between 18 and 65 years
Patients from both sex with American Society of Anaesthesiologists (ASA) physical status I and II.
The subject has signed and dated the written informed consent
The subject is willing and able to fully participate for the duration of the study
Patients who will be posted for free flap reconstruction of oral cancer defects.
Allergy to any of the drugs used in the protocol.
Patients with ASA physical status more than II.
Patients with severe cardiovascular disease or poorly controlled hypertension
Patients with elevated intracranial pressure
Patients with elevated intraocular pressure
Patients who are having moderate or severe hepatic dysfunction
Subjects with past history of psychological illness seriously affecting the subjectâ??s ability to give an informed consent
The subject is, in the opinion of the Institutional Principal Investigator, not an appropriate candidate for study participation
The subject has participated in the study previously and was withdrawn
Screen Failure: All subjects considered for participation and found ineligible must be recorded in the Screen Failure Log. Subject confidentiality is maintained, but reason for exclusion is required.
The subject is part of another active clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objective <br/ ><br>The primary objective of this study is to investigate whether the sub-anaesthetic dosage of ketamine infusion can cause significant reduction of perioperative opioid requirement in patients undergoing free flap reconstruction for head and neck defects. <br/ ><br>Timepoint: 2 years from the start of first recruitment and will be reviewed after every 6 months by the review committee
- Secondary Outcome Measures
Name Time Method 1. post-operative pain of free flap reconstruction patients by NRS (numeric rating scale) between the two groups <br/ ><br>2. amount of rescue analgesics used by the patient in the post-operative period between the groups <br/ ><br>3. post-operative sedation by Richmond agitation and sedation scale between the two groups <br/ ><br> <br/ ><br>Timepoint: 2 years from the start, every 6 months review by the committee