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Trial Outcomes & Findings for Postoperative Opioid Consumption in Gastric Sleeve Surgery (NCT NCT07135154)

NCT ID: NCT07135154

Last Updated: 2026-04-14

Results Overview

A comparison was made based on the equivalent doses of opioid analgesic drugs used in both groups relative to morphine.

Recruitment status

COMPLETED

Target enrollment

96 participants

Primary outcome timeframe

24 hours

Results posted on

2026-04-14

Participant Flow

96 Number of study patients

Of the patient records evaluated for compliance (n=205), 109 did not comply with standard protocols or had incomplete data as follows: 55 patients did not receive patient-controlled analgesia for postoperative pain management, 15 patients did not receive intravenous lidocaine (1.5 mg/kg ideal body weight), 33 patients did not receive intravenous fentanyl (1.0 µg/kg total body weight), and 6 patients lacked records of postoperative analgesic administration.

Participant milestones

Participant milestones
Measure
Fentanyl Group
The control group consisted of patients who underwent surgery using standard balanced anesthesia and fentanyl.
Ketamine Group
The ketamine group consisted of patients who received ketamine infusion during surgery.
Overall Study
STARTED
49
47
Overall Study
COMPLETED
49
47
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Fentanyl Group
n=49 Participants
The control group consisted of patients who underwent surgery using standard balanced anesthesia and fentanyl.
Ketamine Group
n=47 Participants
The ketamine group consisted of patients who received ketamine infusion during surgery.
Total
n=96 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=49 Participants
0 Participants
n=47 Participants
0 Participants
n=96 Participants
Age, Categorical
Between 18 and 65 years
49 Participants
n=49 Participants
47 Participants
n=47 Participants
96 Participants
n=96 Participants
Age, Categorical
>=65 years
0 Participants
n=49 Participants
0 Participants
n=47 Participants
0 Participants
n=96 Participants
Sex: Female, Male
Female
34 Participants
n=49 Participants
32 Participants
n=47 Participants
66 Participants
n=96 Participants
Sex: Female, Male
Male
15 Participants
n=49 Participants
15 Participants
n=47 Participants
30 Participants
n=96 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Turkey
49 Participants
n=49 Participants
47 Participants
n=47 Participants
96 Participants
n=96 Participants
weight
123 kg
STANDARD_DEVIATION 19.21 • n=49 Participants
130 kg
STANDARD_DEVIATION 24.07 • n=47 Participants
126 kg
STANDARD_DEVIATION 21.64 • n=96 Participants

PRIMARY outcome

Timeframe: 24 hours

A comparison was made based on the equivalent doses of opioid analgesic drugs used in both groups relative to morphine.

Outcome measures

Outcome measures
Measure
Fentanyl
n=49 Participants
The control group consisted of patients who underwent surgery using standard balanced anesthesia and fentanyl.
Ketamine
n=47 Participants
The ketamine group consisted of patients who received ketamine infusion during surgery.
Morphine Equivalent Opioid Consumption
40 miligram
Interval 30.0 to 50.0
30 miligram
Interval 20.0 to 43.0

SECONDARY outcome

Timeframe: 24 hours

Postoperative pain is assessed using a numerical pain scale. The Numerical Pain Rating Scale (NRS) was used in the study. NRS pain scores range from 0 (no pain) to 10 (most severe pain)

Outcome measures

Outcome measures
Measure
Fentanyl
n=49 Participants
The control group consisted of patients who underwent surgery using standard balanced anesthesia and fentanyl.
Ketamine
n=47 Participants
The ketamine group consisted of patients who received ketamine infusion during surgery.
Postoperative Pain
5 scores on a scale
Interval 3.0 to 6.0
5 scores on a scale
Interval 4.0 to 6.0

Adverse Events

Fentanyl

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ketamine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

serkan uckun

University of Balikesir

Phone: 535 370 1164

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place