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Effect of insomnia on anaesthetic requirement in patients undergoing laparoscopic cholecystectomy.

Effect of insomnia on anaesthetic requirement in patients undergoing laparoscopic cholecystectomy.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000241437
Enrollment
50
Registered
2016-02-22
Start date
2015-06-01
Completion date
2015-12-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There are several findings about gama-aminobutyric acid (GABA) which is the primary inhibitory neurotransmitter in central nervous system and strongly related with the etiology of chronic insomnia due to abnormal GABA content. GABA is also one of the targets for general anesthetics. We planned to investigate whether the insomnia has any effect on anesthetic requirement.

Interventions

The patients were divided into two groups by using the 4-item Jenkins Sleep Questionnaire(JSQ) due to degree of sleep disturbance . The 4 items were asked to the patients: how frequent they had trouble falling asleep, woke up several times per night, had trouble staying asleep, feeling tired and worn out after the usual amount of sleep during the previous 4 weeks. There were six alternative responses: not at all (1), 1 to 3 days (2), 4 to 7 days (3), 8 to 14 days (4), 15 to 21 days (5) and 22 to

The patients were divided into two groups by using the 4-item Jenkins Sleep Questionnaire(JSQ) due to degree of sleep disturbance . The 4 items were asked to the patients: how frequent they had trouble falling asleep, woke up several times per night, had trouble staying asleep, feeling tired and worn out after the usual amount of sleep during the previous 4 weeks. There were six alternative responses: not at all (1), 1 to 3 days (2), 4 to 7 days (3), 8 to 14 days (4), 15 to 21 days (5) and 22 to 28 days (6). The patients having sleep problems occurring 4 or more times in previous 4 weeks were classified as insomnia group according to sleep disturbances. None of the patients were premedicated. The BIS sensor was applied to patients’ forehead and connected to digital signal converter before the induction of anesthesia. In all groups anesthesia was standardized and induced with propofol 2 mg/kg intravenously, muscle relaxation with rocuronium 0.5mg/kg intravenously. The fentanyl was given to all patients intravenously as a bolus 1 mcg/kg single dose intravenously before induction of anesthesia. Anesthesia was maintained with sevoflurane in a mixture of nitrous oxide 2L/min and oxygen 2L/min, during of procedure and all patients were mechanically ventilated to maintain an ETCO2 concentration of 30-37 mmHg. The BIS target range was maintained between 40-60 via administration of sevoflurane. No further fentanyl was given during operation. Inspiratory and end-tidal concentrations of sevoflurane and ETCO2 were measured. Heart rate, non-invasive arterial blood pressure, arterial oxygen saturation were also measured and recorded during the surgery. All measurements were recorded at 5- min intervals. Pain was assessed in all participants preoperatively and postoperatively. Before the surgery; all participants who were asked about their pain experience lasting for 1 day or more in the past month. They also described their pain on a two-sided blank body manikin (front and back) and categorized into widespread pain, some pain or no pain. Widespread pain is described as pain presented in the both sides of the body, above and below the waist and in the axial skeleton. In cases which all criterias of widespread pain could not be satisfied, it was grouped as some pain. Postoperative abdominal pain was assessed by the patients themselves using numeric rating scale (NRS 0 = no pain, 10= worst possible pain), from 0 to 10 at 2, 4, 8, 12, 18 hours postoperatively. All assessment was done at rest. All patients in both groups were informed about how to use patient controlled intravenous analgesia (PCIA) self-control pump which was administered as soon as possible after the surgery ended. Each PCIA pump contained 300 mg tramadol dilution to 100 ml of 0.9 % saline solution and all of them were adjusted as 10 mg /h background dose and bolus dose of 10 mg, a locked out interval of 15 minutes.

Sponsors

VEYSEL ERDEN
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Inpatients planning to undergo laparoscopic cholecystectomy as an elective surgery

Exclusion criteria

renal failure, thyroid dysfunction, morbid obesity, obstructive sleep apnea, neurological dysfunction, alcoholism, anticonvulsants and opioids usage

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026