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OpenTrials
Completed

NCT Number: NCT04089592

Comparison Of Dexmedetomidine and Fentanyl In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy.

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.

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Key information

Conditions

Cholecystectomy Elective Surgery

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Civil Hospital Karachi, Karachi, Sindh, Pakistan

Loading trial locations.

About this study

This is double-blind, a single centered randomized clinical trial which is based on assessing the hemodynamic stability provided by our study drugs during laryngoscopy and intubation in a patient undergoing laparoscopic cholecystectomy. In addition to that this study will assess the perioperative complication and postoperative recovery in these patients. Laparoscopy has now become the standard technique of choice for cholecystectomy which results in pathophysiological changes characterized by an increase in arterial pressure and heart rate (HR). Many types of research have been done in an attempt to minimize adverse effects by adding adjuvants to the conventional method of general anesthesia. Our research is also based on this aim. The objective of this study to determine the hemodynamic stability during laryngoscopy and intubation, peri-operative complication and post-operative recovery. The patients will be divided into two groups randomly and will be given the desired drugs via intravenous line by on floor consultant anesthetist who will be blinded to the drug. The study subjects' hemodynamics will be observed until 10 minutes of intubation. Any perioperative complication will be noted. The subjects will also be followed postoperatively in recovery to check there sedation score and recovery (Aldrete score) will be noted after 10 minutes after the patient shifted to recovery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA-I and ll patients
  • Male and female patient of age 20-70 years.
  • Undergoing Elective laparoscopic cholecystectomy.

Exclusion criteria

  • Pregnant and lactating females
  • Short thick neck with anticipated difficult intubation.
  • Obese patients.
  • Narcotic addicts.
  • Full stomach patient or with higher chances of aspiration.
  • Patient allergic to any of the study medications.
  • Patients high risk to develop serotonin syndrome. (patient taking an antidepressant and other psychomotor medications.

Treatment and study plan

Dexmedetomidine

Drug

intravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9%

Other names: Fentanyl

Fentanyl

Drug

intravenous fentanyl at 2mcg/kg in 100ml saline

Other names: Dexmedetomidine

Primary outcomes

  1. Systolic blood pressure

    Time frame: at Baseline

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  2. Systolic blood pressure

    Time frame: 0 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  3. Systolic blood pressure

    Time frame: 1 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  4. Systolic blood pressure

    Time frame: 3 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  5. Systolic blood pressure

    Time frame: 5 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  6. Systolic blood pressure

    Time frame: 10 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  7. Diastolic blood pressure

    Time frame: at Baseline

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  8. Diastolic blood pressure

    Time frame: 0 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  9. Diastolic blood pressure

    Time frame: at 1 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  10. Diastolic blood pressure

    Time frame: at 3 minutes

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  11. Diastolic blood pressure

    Time frame: at 5 minutes

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  12. Diastolic blood pressure

    Time frame: at 10 minutes

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  13. Heart rate

    Time frame: at Baseline

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  14. Heart rate

    Time frame: at 0 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  15. Heart rate

    Time frame: at 1 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  16. Heart rate

    Time frame: at 3 minutes

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  17. Heart rate

    Time frame: 5 minutes

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  18. Heart rate

    Time frame: at 10 minutes

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  19. Mean atrial pressure

    Time frame: at Baseline

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  20. Mean atrial pressure

    Time frame: at 0 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  21. Mean atrial pressure

    Time frame: at 1 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  22. Mean atrial pressure

    Time frame: at 3 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  23. Mean atrial pressure

    Time frame: at 5 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  24. Mean atrial pressure

    Time frame: at 10 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  25. SpO (oxygen saturation)

    Time frame: at Baseline

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  26. SpO (oxygen saturation)

    Time frame: at 0 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  27. SpO (oxygen saturation)

    Time frame: at 1 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  28. SpO (oxygen saturation)

    Time frame: at 3 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  29. SpO (oxygen saturation)

    Time frame: at 5 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

  30. SpO (oxygen saturation)

    Time frame: at 10 minute

    Hemodynamic response(induction) will be assessed on different point in time during procedure

Secondary outcomes

  1. Ramsey score

    Time frame: at arrival

    Sedation scale with minimum score 1 indicate good response and maximum score 6 worst response

  2. Ramsey score

    Time frame: at 10 minutes

    Sedation scale with minimum score 1 indicate good response and maximum score 6 worst response

  3. Aldrete score

    Time frame: at arrival

    Post anesthesia Recovery assessment scale with minimum score 0 indicate worst response and maximum score 10 indicate excellent recovery

  4. Aldrete score

    Time frame: at 10 min

    Post anesthesia Recovery assessment scale with minimum score 0 indicate worst response and maximum score 10 indicate excellent recovery

  5. Complications

    Time frame: Will be assessed within Hospital stay at follow for 1 week

    Post operative complication

  6. Laryngospasm

    Time frame: Will be assessed within Hospital stay at follow for 1 week

    Post operative complication

  7. Bradycardia

    Time frame: Will be assessed within Hospital stay at follow for 1 week

    Post operative complication

  8. Regurgitation

    Time frame: Will be assessed within Hospital stay at follow for 1 week

    Post operative complication

  9. Post operative vomiting and nausea

    Time frame: Will be assessed within Hospital stay at follow for 1 week

    Post operative complication

  10. Hypertension

    Time frame: Will be assessed within Hospital stay at follow for 1 week

    Post operative complication

  11. Hypotension

    Time frame: Will be assessed within Hospital stay at follow for 1 week

    Post operative complication

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2019
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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