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Impact of the Use of Ketamine in Laparoscopic Surgery.

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: NCT03724019
Recruitment Status : Active, not recruiting
First Posted : October 30, 2018
Last Update Posted : February 28, 2022
Sponsor:
Information provided by (Responsible Party):
Universidade do Porto

Tracking Information
First Submitted Date October 26, 2018
First Posted Date October 30, 2018
Last Update Posted Date February 28, 2022
Actual Study Start Date October 1, 2018
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 26, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of the Use of Ketamine in Laparoscopic Surgery.
Official Title Evaluation of the Impact of the Use of Ketamine in Laparoscopic Surgery, Using the Quality of Recovery 15 Questionnaire.
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Days
Biospecimen Not Provided
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.
Condition Quality of Recovery
Intervention Drug: Ketamine
Administration of 0.5mg / kg ideal body weight of ketamine at induction of anesthesia in laparoscopic surgery.
Study Groups/Cohorts
  • Group Q
    20 milliliter of ketamine (0.5mg / kg ideal body weight) at induction of anesthesia.
    Intervention: Drug: Ketamine
  • Group S
    20 milliliter of sodium chloride at induction of anesthesia.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: February 25, 2022)
125
Original Estimated Enrollment
 (submitted: October 26, 2018)
80
Estimated Study Completion Date December 1, 2022
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Portugal
Removed Location Countries  
 
Administrative Information
NCT Number NCT03724019
Other Study ID Numbers QuetaminaQOR15
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Current Responsible Party Universidade do Porto
Original Responsible Party Same as current
Current Study Sponsor Universidade do Porto
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Universidade do Porto
Verification Date September 2021