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Intraoperative ketamine infusion for Hemorrhoids

Phase 4
Recruiting
Led By Steven N Carter, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing a hemorrhoidectomy for Grade III or IV hemorrhoids.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-op days 1, 3, 5, 7, and 10
Awards & highlights

Study Summary

This trial is testing whether ketamine can help reduce pain after hemorrhoid surgery.

Who is the study for?
This trial is for adults aged 18-100 who are having surgery (hemorrhoidectomy) for severe hemorrhoids (Grade III or IV). They must be able to have general anesthesia and not use strong painkillers regularly. People with a history of schizophrenia, other hallucinatory psychiatric illnesses, or psychosis cannot participate.Check my eligibility
What is being tested?
The study is testing if ketamine can help with pain after hemorrhoid surgery. About 100 patients will either receive ketamine or no ketamine while under anesthesia, without knowing which group they're in; however, the researchers will know.See study design
What are the potential side effects?
Ketamine may cause side effects such as feelings of disconnection from reality, changes in perception like sights and sounds, confusion, agitation, elevated blood pressure and heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You recently had surgery to remove severe hemorrhoids (Grade III or IV).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two weeks post-operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and two weeks post-operation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in post-operative narcotic usage
Secondary outcome measures
Change in post-op pain

Trial Design

2Treatment groups
Active Control
Group I: Intraoperative ketamine infusionActive Control1 Intervention
Subjects in this group will receive standard anesthesia during surgery and a dose of ketamine at 0.3 mg/kg IV bolus prior to surgical incision. If the procedure lasts more than 1 hour, an additional bolus dose will be given.
Group II: Control groupActive Control1 Intervention
This group will only receive the standard anesthesia during surgery with no ketamine.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
98,021 Total Patients Enrolled
Steven N Carter, MDPrincipal InvestigatorUniversity of Oklahoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for enrollment in this research project?

"Affirmative. Clinicaltrials.gov have recorded that this medical investigation, which had its commencement on June 15th 2020, is actively seeking participants from 1 site to reach a total of 100 patients."

Answered by AI

How many participants are engaged in this research endeavor?

"Yes, the data hosted on clinicaltrials.gov verifies that this medical experiment is currently recruiting for 100 participants from a single site. The initial post was made June 15th 2020 and the trial was most recently modified March 9th 2022."

Answered by AI

Does this experimental program offer the opportunity for me to join?

"This investigation is accepting 100 individuals with Grade III or IV hemorrhoids aged 18 and up. To be considered as a participant, they must have already undergone a hemorrhoidectomy."

Answered by AI

Is enrollment in this study open to individuals over the age of sixty?

"The age range for this clinical trial is 18 to 100, with 13 studies dedicated to minors and 98 specifically targeting those above 65 years of age."

Answered by AI

Is Intraoperative ketamine infusion a safe procedure for patients?

"There is ample evidence and research supporting the safety of intraoperative ketamine infusions, thus it earned a score of 3."

Answered by AI
~17 spots leftby Jan 2025