Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Health Condition 2: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: ketamine injection: Intravenous ketamine infusion in subanesthetic dose in study arm
IV fentanyl infusion in control arm
both arms will get boluses of 0.25 mcg/kg if patient has pai
Sponsors
TMC trust
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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not an appropriate candidate for study participation The subject has participated in the study previously and was withdrawn Screen Failure: All subjects considered for participation and found ineligible must be recorded in the Screen Failure Log.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective 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. Timepoint: 2 years from the start of first recruitment and will be reviewed after every 6 months by the review committee | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. post-operative pain of free flap reconstruction patients by NRS (numeric rating scale) between the two groups 2. amount of rescue analgesics used by the patient in the post-operative period between the groups 3. post-operative sedation by Richmond agitation and sedation scale between the two groups Timepoint: 2 years from the start, every 6 months review by the committee | — |
Countries
India
Contacts
Public ContactRakhi Khemka
Tata Medical Center
Outcome results
None listed