Impact of the Use of Ketamine in Laparoscopic Surgery.

NCT ID: NCT03724019

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2023-04-01

Brief Summary

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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

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Conditions

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Quality of Recovery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Group Q

20 milliliter of ketamine (0.5mg / kg ideal body weight) at induction of anesthesia.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Administration of 0.5mg / kg ideal body weight of ketamine at induction of anesthesia in laparoscopic surgery.

Group S

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ketamine

Administration of 0.5mg / kg ideal body weight of ketamine at induction of anesthesia in laparoscopic surgery.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients between 18 and 65 years age, with an American Society of Anesthesiology physical status I, II or III.
* Laparoscopic surgery (sleeve gastrectomy, salpingectomy, or cholecystectomy)

Exclusion Criteria

* patient refusal, the incapacity of providing informed consent, 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU São João

Porto, , Portugal

Site Status

Countries

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Portugal

References

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Pereira H, Graca MI, Fonseca D, Mendes-Castro A, Abelha F. Impact of Ketamine on Quality of Recovery after Laparoscopic Surgery: A Single-Centre Single-Blinded Trial Using the QoR-15 Questionnaire. Anesthesiol Res Pract. 2023 Jan 20;2023:8890025. doi: 10.1155/2023/8890025. eCollection 2023.

Reference Type DERIVED
PMID: 36714040 (View on PubMed)

Other Identifiers

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QuetaminaQOR15

Identifier Type: -

Identifier Source: org_study_id

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