Cholecystectomy Clinical Trial
Official title:
Comparison Of Dexmedetomidine and Fentanyl In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy.
NCT number | NCT04089592 |
Other study ID # | SUrooj |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 15, 2019 |
Est. completion date | July 15, 2019 |
Verified date | September 2019 |
Source | Dow University of Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Compare effects of intravenous dexmedetomidine and fentanyl in attenuation of intubation
response in a patient undergoing laparoscopic cholecystectomy.
Compare the effects of intravenous dexmedetomidine and fentanyl in sedation, perioperative
complications, and recovery in these patients.
Dexmedetomidine is comparatively a newer drug in countries like Pakistan. There is no
research work available at the national level and scarcity of data at an international level
with inconclusive outcomes. Our participation in the form of this research will add to
scientific literature and step up ahead at the international level.
Fentanyl citrate is a narcotic analgesic interacting predominantly with the opioid μ receptor
and exerting its principal pharmacological effect on CNS. Its primary action of therapeutic
value is analgesia and sedation. It is extensively used for anesthetic and analgesic most
often in operating room and ICU.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 15, 2019 |
Est. primary completion date | May 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. ASA-I and ll patients 2. Male and female patient of age 20-70 years. 3. Undergoing Elective laparoscopic cholecystectomy. Exclusion Criteria: 1. Pregnant and lactating females 2. Short thick neck with anticipated difficult intubation. 3. Obese patients. 4. Narcotic addicts. 5. Full stomach patient or with higher chances of aspiration. 6. Patient allergic to any of the study medications. 7. Patients high risk to develop serotonin syndrome. (patient taking an antidepressant and other psychomotor medications. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Civil Hospital Karachi | Karachi | Sindh |
Pakistan | DUHS, Civil hospital Karachi (CHK) | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Dow University of Health Sciences |
Pakistan,
Vaswani JP, Debata D, Vyas V, Pattil S. Comparative Study of the Effect of Dexmedetomidine Vs. Fentanyl on Haemodynamic Response in Patients Undergoing Elective Laparoscopic Surgery. J Clin Diagn Res. 2017 Sep;11(9):UC04-UC08. doi: 10.7860/JCDR/2017/27020 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Systolic blood pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | at Baseline | |
Primary | Systolic blood pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | 0 minute | |
Primary | Systolic blood pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | 1 minute | |
Primary | Systolic blood pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | 3 minute | |
Primary | Systolic blood pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | 5 minute | |
Primary | Systolic blood pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | 10 minute | |
Primary | Diastolic blood pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | at Baseline | |
Primary | Diastolic blood pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | 0 minute | |
Primary | Diastolic blood pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 1 minute | |
Primary | Diastolic blood pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 3 minutes | |
Primary | Diastolic blood pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 5 minutes | |
Primary | Diastolic blood pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 10 minutes | |
Primary | Heart rate | Hemodynamic response(induction) will be assessed on different point in time during procedure | at Baseline | |
Primary | Heart rate | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 0 minute | |
Primary | Heart rate | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 1 minute | |
Primary | Heart rate | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 3 minutes | |
Primary | Heart rate | Hemodynamic response(induction) will be assessed on different point in time during procedure | 5 minutes | |
Primary | Heart rate | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 10 minutes | |
Primary | Mean atrial pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | at Baseline | |
Primary | Mean atrial pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 0 minute | |
Primary | Mean atrial pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 1 minute | |
Primary | Mean atrial pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 3 minute | |
Primary | Mean atrial pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 5 minute | |
Primary | Mean atrial pressure | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 10 minute | |
Primary | SpO (oxygen saturation) | Hemodynamic response(induction) will be assessed on different point in time during procedure | at Baseline | |
Primary | SpO (oxygen saturation) | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 0 minute | |
Primary | SpO (oxygen saturation) | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 1 minute | |
Primary | SpO (oxygen saturation) | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 3 minute | |
Primary | SpO (oxygen saturation) | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 5 minute | |
Primary | SpO (oxygen saturation) | Hemodynamic response(induction) will be assessed on different point in time during procedure | at 10 minute | |
Secondary | Ramsey score | Sedation scale with minimum score 1 indicate good response and maximum score 6 worst response | at arrival | |
Secondary | Ramsey score | Sedation scale with minimum score 1 indicate good response and maximum score 6 worst response | at 10 minutes | |
Secondary | Aldrete score | Post anesthesia Recovery assessment scale with minimum score 0 indicate worst response and maximum score 10 indicate excellent recovery | at arrival | |
Secondary | Aldrete score | Post anesthesia Recovery assessment scale with minimum score 0 indicate worst response and maximum score 10 indicate excellent recovery | at 10 min | |
Secondary | Complications | Post operative complication | Will be assessed within Hospital stay at follow for 1 week | |
Secondary | Laryngospasm | Post operative complication | Will be assessed within Hospital stay at follow for 1 week | |
Secondary | Bradycardia | Post operative complication | Will be assessed within Hospital stay at follow for 1 week | |
Secondary | Regurgitation | Post operative complication | Will be assessed within Hospital stay at follow for 1 week | |
Secondary | Post operative vomiting and nausea | Post operative complication | Will be assessed within Hospital stay at follow for 1 week | |
Secondary | Hypertension | Post operative complication | Will be assessed within Hospital stay at follow for 1 week | |
Secondary | Hypotension | Post operative complication | Will be assessed within Hospital stay at follow for 1 week |
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