Impact of the Use of Ketamine in Laparoscopic Surgery.

• Sponsor: Universidade do Porto (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03724019
• Collaborator: (none)
• Enrollment: 125
• Location: 1
• Anticipated Duration (Months): 50
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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	Phase
Quality of Recovery	Drug: Ketamine

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 125 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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: Oct 1, 2018
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Impact in QoR-15 score [6 months]

   Difference (improvement or worsening) in the postoperative baseline score (preoperative) in the Portuguese version of the Quality of Recovery questionnaire 15.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU São João	Porto		Portugal	4200

Sponsors and Collaborators

• Universidade do Porto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universidade do Porto
• ClinicalTrials.gov Identifier: NCT03724019
• Other Study ID Numbers: QuetaminaQOR15
• First Posted: Oct 30, 2018
• Last Update Posted: Feb 28, 2022
• Last Verified: Sep 1, 2021

• 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: Ketamine

Study Results

No Results Posted as of Feb 28, 2022