Khanduja 2013.
Methods | RCT, single‐blinded, 2 parallel groups | |
Participants |
Number: 60 men (n = 12) and women (n = 48) Country: India Surgery: laparoscopic cholecystectomy, general anaesthesia, elective ASA: not reported, probably I and II (judged by exclusion criteria) Age: 20 to 65 years Other inclusion criteria: none reported Exclusion criteria: anaemia, long‐term medications or any medication within 1 week before surgery, history of any chronic disease, cardiac problem, history of drug abuse, consumption of more than 30 g alcohol/d, use of β‐blockers and abnormal preoperative electrolyte concentrations |
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Interventions |
vs
All participants:
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Outcomes | Number of participants with postoperative pain. No time point specified, but probably immediately after extubation | |
Notes | A significant difference was reported in the total amount of administered pentazocine (mg, mean, SD): 17.9 ± 4.13 in the dexmedetomidine group vs 29.4 ± 4.272 in the placebo group (P value < 0.001), including intraoperative need and predetermined difference in induction dose Duration of study ≥ 30 minutes after surgery, not further specified. Study authors contacted for details of follow‐up, random sequence generation, allocation concealment, etc, without luck |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: "...randomized..." Comment: not reported how |
Allocation concealment (selection bias) | Unclear risk | Nothing reported |
Blinding of participants and personnel (performance bias) Pain, 'rescue' analgesia, postoperative sedation | Low risk |
Quote: " ...single blinded..." Comment: probably non‐blinded anaesthesiologist assessing all outcomes (time of follow‐up approximately 30 minutes after surgery). This could have influenced the intraoperatively administered amount of pentazocine, which was significantly different between groups. An unblinded anaesthesiologist might have an interest in showing reduced need for intraoperative analgesia/anaesthesia in the intervention group, or he might anticipate that participants would have more pain. Thus, the possible direction of bias would be to underestimate the effect of intervention; therefore the risk of bias was low |
Blinding of participants and personnel (performance bias) PONV | Unclear risk | Not relevant |
Blinding of participants and personnel (performance bias) Time to first passage of flatus or stool | Unclear risk | Not relevant |
Blinding of participants and personnel (performance bias) Time to first out‐of‐bed mobilization | Unclear risk | Not relevant |
Blinding of participants and personnel (performance bias) Post‐interventional complications or side effects | Unclear risk | Not relevant |
Blinding of outcome assessment (detection bias) Pain, 'rescue' analgesia, postoperative sedation | Low risk |
Quote: "...single blinded..." Comment: the same comment as under performance bias |
Blinding of outcome assessment (detection bias) PONV | Unclear risk | Not relevant |
Blinding of outcome assessment (detection bias) Time to first passage of flatus or stool | Unclear risk | Not relevant |
Blinding of outcome assessment (detection bias) Time to first out‐of‐bed mobilization | Unclear risk | Not relevant |
Blinding of outcome assessment (detection bias) Post‐interventional complications or side effects | Unclear risk | Not relevant |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete data |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to allow a judgement; no protocol available |
Other bias | Unclear risk | Insufficient information to allow a clear judgement |