Impact of the Use of Ketamine in Laparoscopic Surgery.

• ClinicalTrials.gov Identifier: NCT03724019
• Recruitment Status: Active, not recruiting
• First Posted: October 30, 2018
• Last Update Posted: February 28, 2022
• Sponsor: Universidade do Porto
• 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
• 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

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

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