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Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy (lap)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03180229
Recruitment Status : Completed
First Posted : June 8, 2017
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital

Brief Summary:

Propofol is one of the most commonly used anesthetic agents because of its ability to induce rapid and reliable collection. However, hypotension and injection pain in the induction are the most common complications. After induction of propofol; The cardiovascular system depresses, resulting in a drop in blood pressure due to decreased cardiac output and systemic vascular resistance. This may also contribute to the reduction of sympathetic tone activity in the central way, and slight reduction in the number of pulses that develop as a result of increasing vagal activity. İn order to attenuate these hemodynamic undesired effects caused by propofol, various agents were tried such as atropine, ephedrine, volume replacement ringer lactate, ketamine. Ondansetron and granisetron, which are used for postoperative nausea and vomiting prophylaxis, have been used as such. Therefore, ondansetron and granisetron were preventing hypotension induced by post-spinal and general anesthesia induction.

The investigator also tried to demonstrate the effect of granisetron, another serotonin type 3 (5-HT3) receptor antagonist for postoperative nausea and vomiting prophylaxis, on induction hypotension and intubation quality after propofol induction in this study


Condition or disease Intervention/treatment Phase
Cholelithiasis Drug: Granisetron 1 Mg/mL Intravenous Solution Phase 4

Detailed Description:

150 participants with American Society of Anesthesiologists (ASA) physical score I-II who underwent elective laparoscopic cholecystectomy between the ages of 18-70 will be enrolled. Participants will be divided into two groups using granisetron and control.

All participants will be premedicated with 0.05 mg kg-1 midazolam 30 minutes before the operation. ASA, age, sex, weight demographic data of the participants who were taken to the operating room will record. Peripheral oxygen saturation (SPO2), noninvasive blood pressure and electrocardiography (ECG) will monitored. A venous cannula will place on the back of the hand. Participants will randomly divide into 2 groups by closed envelope method.

Five minutes before the induction of group G, 1 ml (1 mg / ml) iv granisetron, group K will receive 1 ml saline. Propofol at induction will be administered at a dose of 0.6 mg / kg of rocuronium at a dose of 2 mg / kg. Pre-induction, post-intubation and every five minutes SPO2, diastolic arterial pressure (DAP), mean arterial pressure (MAP), systolic arterial pressure(SAP) and heart rate (HR) will record. Intubation quality will be evaluated by evans score.

Systolic Blood Pressure <Control + 15 0 <Control + 30 1 1

  • Control + 30 2 Heart Rate Pressure <Control + 15 0 <Control + 30 1
  • Control + 30 2 Sweating No 0 Moist leather 1 Visible sweating 2 Tears No 0 Yes 1 Overflowing 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Granisetron Effect on Hemodynamic Changes and Intubation Condition During Anesthesia Induction in Laparoscopic Cholecystectomy
Actual Study Start Date : May 29, 2017
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : December 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
Drug Information available for: Granisetron

Arm Intervention/treatment
Active Comparator: Granisetron
Five minutes before the induction 1 ml (1 mg / ml) iv granisetron will use. .Then blood pressure (systolic, diastolic, mean) and heart rate will record per 5 minute during surgery.
Drug: Granisetron 1 Mg/mL Intravenous Solution
1 milligram (mg) will use on group Granisetron before 5 min induction

No Intervention: Control
Five minutes before the induction 1 ml saline iv use.Then blood pressure (systolic, diastolic, mean) and heart rate will record per 5 minute during surgery.



Primary Outcome Measures :
  1. change mean arterial blood pressure [ Time Frame: Change from Baseline Systolic Blood Pressure at per 5 minute during surgery ]
    mean arterial blood pressure (MAP) MAP at least 25% less than the basal value

  2. intubation quality [ Time Frame: intubation period ]
    in this time evans score which is included tears, sweating, systolic arterial blood pressure and heart rate will be used. the change baseline systolic arterial blood pressure and heart rate and tears, sweating will score numeric.

  3. change heart rate [ Time Frame: Change from baseline heart rate at per 5 minute during surgery ]
    HR <60 or >25% drop baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18-70
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Laparoscopic Cholecystectomy (lap) surgery

Exclusion Criteria:

  • Acute pancreatitis disease
  • Cardiorespiratory disease
  • Hypertension
  • Anti hypertension treatments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180229


Locations
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Turkey
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey
Ankara, Turkey
Sponsors and Collaborators
Diskapi Yildirim Beyazit Education and Research Hospital

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Responsible Party: Savas Altinsoy, Principal Investigator, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03180229    
Other Study ID Numbers: Diskapi
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Granisetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action