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CompletedNCT03724019Updated May 10, 2023

Impact of the Use of Ketamine in Laparoscopic Surgery.

A Phase 4 interventional study of Ketamine in Quality of Recovery, sponsored by Universidade do Porto. Completed at 1 site in Portugal. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-10.

Sponsored by Universidade do Porto · Phase 4, Interventional, and Screening

From the registry’s dates

  • Primary completion was Oct 2022, 4 years ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
127
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Quality of Recovery

Keywords

  • Ketamine
  • QoR-15
  • Laparoscopic surgery
03

In context

Lead sponsor

Universidade do Porto is the lead sponsor of 170 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Phase 4
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
127 participants (actual)

Study arms

  • Experimental
    Group Q

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

    Drug: Ketamine

  • No intervention
    Group S

Interventions

  • DrugKetamine

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

06

What researchers measure

Primary outcomes

  1. Impact in QoR-15 score

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

    Time frame: 6 months

07

Study locations

1 site
  • CHU São João
    Porto, 4200, Portugal
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03724019
Lead sponsor
Universidade do Porto
Responsible party
Sponsor
First posted
Oct 30, 2018
Start date
Oct 1, 2018
Primary completion
Oct 1, 2022
Completion
Apr 1, 2023
Last update
May 10, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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