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Clinical Trials/CTRI/2024/04/066065
CTRI/2024/04/066065Not yet recruitingPhase 1/2

Opioid Free anethesia for nasal surgeries A comparative study

Sapthagiri Institute Of Medical Sceinces and Research Centre1 site in 1 country60 target enrollmentStarted: May 6, 2024Last updated:

Trial Snapshot

Phase
Phase 1/2
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Duration of post operative analgesia in both the groups for 1st 24 hours

Study Overview

Brief Summary

Functional endoscopic sinus surgery (FESS) is the most commonly performed otolaryngological procedures.This surgery is usually conducted under general anesthesia under controlled hypotension improve surgical field and to increases the likelihood of successful surgery. Opioid-sparing techniques are gaining popularity among anesthesiologist due to opioid related side effects. Here we are comparing opioid free and opioid based general anesthesia groups in nasal surgeries with respect to post-operative analgesia, post operative nausea and vomiting, hemodynamics stability. Results of this study will guide us about the benefits  and advantages of opioid free anesthesia.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
15.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA 1 and 2, undergoing elective bilateral functional endoscopic sinus surgery.

Exclusion Criteria

  • Allergy/contraindication to any drugs used in this study Bleeding disorders Unstable hemodynamics Pregnant patients Patients currently taking opioid for chronic pain Patients with asymptomatic sinus bradycardia Patients with OSA, obesity, difficult airway.

Outcomes

Primary Outcomes

Duration of post operative analgesia in both the groups for 1st 24 hours

Time Frame: Duration of post operative analgesia in both the groups for 1st 24 hours

Secondary Outcomes

  • Comparition of both groups with respect to post operative nausea and vomiting, hemodynamics stability(post operative nausea and vomiting episodes)

Investigators

Sponsor
Sapthagiri Institute Of Medical Sceinces and Research Centre
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Sahana S

Sapthagiri institute of Medical Sciences and Research Centre

Study Sites (1)

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