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Impact of the Use of Ketamine in Laparoscopic Surgery.

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ClinicalTrials.gov Identifier: NCT03724019
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Universidade do Porto

Brief Summary:
In order to improve the postoperative period (namely pain control), several drugs can be used. For instance, ketamine is a general anesthetic that holds strong analgesic properties, yet also owns undesirable effects, in which hallucination phenomena is one the most common indicator. However, slight information is available about the real implication in the quality of the recovery on the use of ketamine for postoperative pain treatment. The quality of the recovery includes several health conditions, such as pain, physical comfort, physical independence, psychological support and emotional state. In recent years, investigations in this field has been attracted the attention by the health professionals, since is an indicator of the quality of post-operative care. To evaluate these parameters, questionnaires have been developed, in which the Portuguese version of Quality of Recovery 15 (QoR-15) is include. This questionnaire evaluates five psychometric dimensions. Therefore, the present study has the main goal, the evaluation of the effect of using ketamine in laparoscopic surgery and the quality of the recovery using the QoR-15 questionnaire.

Condition or disease Intervention/treatment
Quality of Recovery Drug: Ketamine

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Evaluation of the Impact of the Use of Ketamine in Laparoscopic Surgery, Using the Quality of Recovery 15 Questionnaire.
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Group/Cohort Intervention/treatment
Group Q
20 milliliter of ketamine (0.5mg / kg ideal body weight) at induction of anesthesia.
Drug: Ketamine
Administration of 0.5mg / kg ideal body weight of ketamine at induction of anesthesia in laparoscopic surgery.

Group S
20 milliliter of sodium chloride at induction of anesthesia.



Primary Outcome Measures :
  1. Impact in QoR-15 score [ Time Frame: 6 months ]
    Difference (improvement or worsening) in the postoperative baseline score (preoperative) in the Portuguese version of the Quality of Recovery questionnaire 15.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients submitted to laparoscopic surgery at the Hospital Center of São João (Oporto / Portugal) in General Surgery (abdominal surgery), Urology (Nephrectomy) or Gynecology (Hysterectomy) and admitted to the PACU.
Criteria

Inclusion Criteria:

  • Patients between 18 and 65 years age, with an American Society of Anesthesiology physical status I or II.

Exclusion Criteria:

  • drug abusers (current or past history) or alcohol abuse, medication with benzodiazepines, inability to give informed consent, pregnant, emergency surgery, psychiatric pathology, existence of surgical complications in the recovery and admission to a level II or III unit ( for any reason).

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): NCT03724019


Locations
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Portugal
CHU São João Recruiting
Porto, Portugal, 4200
Contact: Helder Pereira    +351225512100    u008909@chsj.min-saude.pt   
Sponsors and Collaborators
Universidade do Porto

Additional Information:

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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT03724019     History of Changes
Other Study ID Numbers: QuetaminaQOR15
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Universidade do Porto:
Ketamine
QoR-15
Laparoscopic surgery
Additional relevant MeSH terms:
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Ketamine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action